At Biomet, engineering excellence is our heritage and
our passion. For over 25 years, through various
divisions worldwide, we have applied the most
advanced engineering and manufacturing technology
to the development of highly durable systems for a
wide variety of surgical applications.
PhoenixTM Tibial Nail System
Featuring CoreLockTM Technology
To learn more about this product,
contact your local Biomet Sales Representative today.
All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless
otherwise indicated.
This material is intended for the sole use and benefit of the Biomet sales force
and health care professionals. It is not to be redistributed, duplicated or disclosed
without the express written consent of Biomet.
For product information, including indications, contraindications, warnings,
precautions and potential adverse effects, see the package insert and Biomet’s
website.
Responsible Manufacturer
Biomet, Inc.
P.O. Box 587
56 E. Bell Drive
Warsaw, Indiana 46581-0587
USA
©2013 Biomet Orthopedics • Form No. BMET0350.0 • REV011513
www.biomet.com
Rx only.
Surgical Technique
PhoenixTM
Tibial Nail System
Featuring
CoreLock Technology
TM
• Each nail features CoreLockTM Technology, a preassembled,
embedded locking mechanism for locking all proximal oblique
screws, which can also be used to internally mechanically
compress up to 5mm for a variety of tibial fractures
•
Distally, the tibial nail offers an exceptionally low distal aspect
of 4.5mm from the center of the most distal screw hole to the
nail tip and 10mm from the center of the second most distal
screw hole from the cluster to the nail tip for treatment of
very distal fractures
Contents
Introduction................................................... Page 1
Indications and Contraindications.................. Page 2
Design Features............................................ Page 3
Surgical Technique ....................................... Page 6
Product Ordering Information ........................ Page 31
Package Insert .............................................. Page 36
Further Information ....................................... Page 39
Introduction
The Phoenix™ Tibial Nail System is composed of titanium alloy
and features CoreLock™ Technology that offers a preassembled,
embedded locking mechanism for locking all proximal oblique
screws, which can also be used to internally mechanically
compress up to 5mm for a variety of tibial fractures. Distally, the
tibial nail offers an exceptionally low distal aspect of 4.5mm from
the center of the most distal screw hole to the nail tip and 10mm
from the center of the second most distal screw hole of the cluster
to the nail tip for treatment of very distal fractures.
The tibial nail is universal and available in outer diameters of
7.5mm, 9mm, 10.5mm, 12mm and 13.5mm for applications
in a wide variety of patients in lengths of 240mm-420mm, in
10mm increments. Additionally, the system features a strong,
lightweight Radiolucent Targeting Arm that permits radiographic
visualization in multiple planes. With its easy to use color-coded
instrumentation conveniently contained in a single tray and its
innovative implant design, the PhoenixTM Tibial Nail System is
designed to address both patient and surgeon needs.
1
Indications
INDICATIONS
CONTRAINDICATIONS
Phoenix Tibial Nail System
The Phoenix Tibial Nail System is indicated for alignment,
stabilization, and fixation of fractures caused by trauma or
disease, and the fixation of long bones that have been surgically
prepared (osteotomy) for correction of deformity and for
arthrodesis.
1. Infection.
2. Patient conditions including blood supply limitations, and
insufficient quantity or quality of bone.
3. Patients with mental or neurologic conditions who are
unwilling or incapable of following postoperative care
instructions.
4. Foreign body sensitivity. Where material sensitivity is
suspected, testing is to be completed prior to implantation of
the device.
2
Design Features
9° Bend
18.5mm
24.5mm
29mm
63.5mm
(Proximal
Bend
Location)
39mm
Proximal Oblique
Screw Holes
49mm
Dynamic/
Compression
Slot
10mm
Static Hole
OBL
90°
OBL
45°
45°
M/L
M/L
45°
45°
OBL
OBL
90°
15.6mm
10mm
1.8mm*
4.5mm
*2.4mm for 7.5mm nail only
3°
Distal
Bend
51mm
(Distal Bend Location)
Note: Views are not to scale and should be used for reference only.
3
Design Features (Continued)
CoreLock™ Technology
Innovation made simple and elegant through deployment of the
preassembled, embedded setscrew/locking mechanism.
Ability to lock proximal oblique screws to nail via preassembled,
embedded setscrew/locking mechanism.
5mm of internal mechanical compression via embedded
setscrew/locking mechanism.
7.5mm
9mm
10.5mm
12mm
13.5mm
Nail diameters offered:
7.5mm, 9mm, 10.5mm, 12mm and 13.5mm
Offered in lengths ranging from 240mm-420mm (10mm
increments)
Proximal diameter for 7.5mm, 9mm and 10.5mm nail is 11mm
Since the holes within the embedded setscrew are grooved,
proximal screw removal can be achieved without disengaging the
Proximal diameter for 12mm nail is 12mm
Proximal diameter for 13.5mm nail is 13.5mm
embedded setscrew.
4
Double-Lead Thread Screws
- Composed of Titanium Alloy
- Features a double-lead thread design for quick insertion
- Self-tapping tip
- Interior of 4mm and 5mm cortical screw head is threaded
for secure retention to inserter
- Threads are closer to screw head and screw tip for better
bicortical purchase
4mm Double-Lead Thread Screw
- Used distally for locking 7.5mm nail only
- Color-coded gold
4mm Screw Lengths:
20mm – 58mm
(Available in 2mm increments)
3.5mm Inserter Connector
(Long & Short) retains head
of screw
Interior of screw head is
threaded for retention to
inserter
End Caps
3.5mm Inserter Connector retains head of end cap
to facilitate easier insertion
0mm
5mm
10mm
15mm
20mm
5mm Double-Lead Thread Screw
- Utilized for proximal locking all nail sizes
- Used distally for locking 9mm, 10.5mm and 12mm nail sizes
- Color-coded light green
5mm Screw Lengths:
20mm – 60mm
(Available in 2mm increments)
65mm – 110mm
(Available in 5mm increments)
5
Surgical Technique
Step 1. Preoperative Planning
Step 2. Patient Positioning And Preparation
Successful nailing of extreme distal tibia fractures is dependent
The patient is placed in a supine position on a radiolucent
upon careful preoperative planning and patient evaluation.
operating table, preferably one without metal sides for ease
of imaging. Flex the knee 90° or greater over a knee triangle
To fully understand the fracture pattern, a complete radiographic
or several rolled towels to provide access for adequate tissue
evaluation of the entire tibia must be obtained. For those fractures
clearance of instruments.
within 4cm of the physeal scar, formal ankle radiographs are
necessary to accurately assess the bone available for distal
The affected extremity should be prepped and draped free. A
locking. Careful scrutiny is mandatory, in order to delineate the
thigh tourniquet may be used, but should not be left inflated
presence or absence of any intra-articular pathology. Preoperative
while intramedullary reaming is performed. Alternatively, a
planning with the use of implant templates can be helpful to
traction table or femoral distractor can be used to obtain fracture
assess whether distal locking is possible.
reduction and maintain length while the nailing is performed.
If grade IV comminution is present, radiographs of the
contralateral side will be necessary to help obtain the correct
length of the injured extremity. Alternatively, the contralateral
side can be measured with the C-arm intraoperatively, prior to
prepping and draping, using a radiopaque ruler and fluoroscopy.
This will allow for the appropriate length nail to be chosen to
accurately restore the length of the
fractured tibia.
6
Step 3. Surgical Exposure
A sagittal midline incision, centered over the patellar tendon,
is made from the center of the patella to the top of the tibial
plateau. The patellar tendon should be exposed to the level of the
paratendon. Either a lateral or medial parapatellar approach is
performed, but the knee joint should not be entered. The patella
fat pad should only be cleared anteriorly to permit entry for proper
portal placement.
Step 4. Entry Point
A 3.2mm x 460mm Entry Guide Wire (Catalog #27914) is placed
just distal to the articular margin, as viewed on the lateral
radiograph. On an A/P image, the entrance portal will be just
medial to the lateral tibial eminence or just lateral to the midline.
This position decreases risk of injury to the menisci, articular
cartilage and ACL. Confirm placement of the Guide Wire using the
C-arm image.
9°
M
L
7
Surgical Technique (Continued)
Step 5. Opening The Medullary Canal
Alternatively, a Curved Cannulated Awl (Catalog #41026) attached
to a Modular T-Handle, Non-Ratcheting (Catalog #29407) can be
Place the Working Channel Soft Tissue Sleeve (Catalog #41029)
used to obtain the entrance portal.
and the 11.5mm One-Step Reamer (Catalog #41009) over the
Guide Wire to enlarge the entry site and drill until entering the
canal.
11.5mm
Diameter
For protection of the Modular T-Handle, Non-Ratcheting during
insertion of the Curved Cannulated Awl, use of the Impactor Cap
(Catalog #14-441047) is recommended.
8
Step 6. Fracture Reduction And Guide Wire Placement
Fracture reduction is performed manually, with use of an image
intensifier to aide with positioning. If the canal is to be reamed,
a 2.6mm x 80cm Bead Tip Guide Wire (14-410002) is inserted
through the opening in the proximal tibia and advanced to the
level of the fracture. Images are checked as the Guide Wire is
passed across the fracture site. An A/P and lateral image should
confirm an intramedullary position of the Guide Wire in the
center of the distal fragment in both planes. To help facilitate
Guide Wire passage through the fracture site, the Keyless Chuck
T-Handle (Catalog #14-442078) may be used. The Guide Wire
may be gently impacted into the distal metaphysis to the level of
the physeal scar to prevent accidental removal of the guide wire
during reaming.
9
Surgical Technique (Continued)
In the case of a non-union, where the path to the canal is
blocked and unlikely to advance a guide wire or entry reamer
across the fracture site, a Pseudarthrosis Pin Straight (Catalog
#14-442073) or Curved (Catalog #14-442074) may be used
to create an opening for the passage of a guide wire for canal
reaming.
5mm
In the event of a displaced fracture, the 8.5mm Fracture Reducer
(Bowed) (Catalog #14-442068) may be used to facilitate Guide
Wire insertion through the fracture site.
10
Step 7. Determining Nail Length
To measure nail length, a direct reading can be made at the
juncture of the two tubes. The nail should be countersunk to
The Telescoping Nail Measuring Gauge (Catalog #14-440047)
prevent any impingement. The selected nail should be at least
is placed over the 2.6mm Bead Tip Guide Wire, until it rests
1cm shorter than the measured medullary canal to permit
on the anterior cortex. The nail should come to rest in the
countersinking of the proximal end of the nail.
distal metaphysis and can be inserted as distal as the physeal
scar. Choose the appropriate nail on this basis. With the Guide
Alternatively, either a second Guide Wire of equal length may be
Wire resting at the desired distal level, the telescoping tube is
used to measure the length of the medullary canal or use of a
extended to the end of the Guide Wire.
Medullary Canal and Length Estimator (Catalog #14-442075) may
be used to determine nail diameter and length.
11
Surgical Technique (Continued)
Step 8. Intramedullary Reaming
Upon attaching the 8mm diameter Modular Reamer Head to
the Flexible Nitinol Reamer Shaft (40cm-Catalog #27958 or
52cm-Catalog #27940), begin reaming over the Bead Tip Guide
Wire in 1mm increments until cortical chatter occurs and then in
0.5mm increments. It is recommended that the surgeon ream to
1mm greater than the diameter of the nail to be inserted.
During medullary canal reaming, the Wire Pusher (Catalog
Reamer head
diameters available
from 8mm to 14.5mm
(0.5mm increments)
#41027) can be used to help retain the 2.6mm Bead Tip Guide
Wire during reamer extraction.
Note: The 8mm reamer
head is the only forward
cutting reamer head; all
others are side-cutting.
Note: Since the 2.6mm Bead Tip Guide Wire (Catalog #14-410002)
will pass through all PhoenixTM Tibial Nail diameter cannula, an
exchange technique is not required.
Note: Wire Pusher
features multiple bores.
12
Step 9. Nail Assembly
Note: To ensure accurate proximal targeting, attach the Tibial
Nail Targeting Arm (Catalog #41000) to the Driver Handle and
Attach the Driver Handle (Catalog #41018) to the proximal aspect
insert the Soft Tissue Guide, Drill Sleeve and 4.3mm Calibrated
of the tibial nail, ensure the slope is anterior and the three tangs
Drill Bit through the associated arm slot to ascertain accuracy.
on the underside of the Driver Handle engage with the three slots
Upon confirming accurate trajectories, remove the Targeting Arm
of the nail. Place the Connecting Bolt (Catalog #41002) into the
and guides, if desired.
Driver Handle and proceed to thread into the nail and secure
using a 5mm Connecting Bolt Inserter (Catalog #41003) attached
to the Modular T-Handle, Non-Ratcheting (Catalog #29407).
Incorrect
Driver Handle
nose shown
fully seated
to the nail
13
Surgical Technique (Continued)
Step 10. Nail Insertion
The tibial nail is inserted manually over the Bead Tip Guide Wire
and advanced into the medullary canal. The fracture should be
adequately reduced and out to length during insertion of the nail
and should be monitored with the image intensifier. The Bead Tip
Guide Wire is removed after the nail passes the fracture site. The
nail can be countersunk to the level indicated by the groove on
the driver nose. Final nail positioning should be checked in both
A/P and lateral views to ensure proper alignment.
If a Slotted Mallet (Catalog #14-442053) is desired to seat the
nail into the canal, thread the Slap Hammer Adapter (Catalog
#41001) into the Driver Handle and attach the Slap Hammer Shaft
(Catalog #29448). To avoid nail misalignment, do not strike the
Driver Handle directly.
Note: It is recommended to only attach the Targeting Arm to the
Driver Handle once the tibial nail has been completely seated into
the canal, to avoid potential loosening.
20mm
15mm
29mm
10mm
5mm
Note: Grooves on the Driver Handle nose help indicate depth
when countersinking.
14
Step 11. Determining Screw Length And Screw Insertion
Determining the length of the appropriate screw size for distal
Determining the appropriate 5mm screw length for proximal
locking can be achieved by using a Screw Depth Gauge - Extra
locking can be achieved by using a Screw Depth Gauge - Extra
Short (Catalog #14-442082) or overlay the 4.3mm x 152mm
Long (Catalog #14-442081) or the appropriate screw length is
Short Drill Bit (Catalog #27984) with the Short 4.3mm Drill
measured off the 4.3mm Calibrated Drill Bit, at the end of the
Measuring Sleeve (Catalog #14-442076). Measurement is read
Drill Sleeve
at the end of the drill bit.
NOTE: The 4mm screws are used distally with the
7.5mm nail only.
15
Surgical Technique (Continued)
Screw Insertion
When inserting distal screws, place the 3.5mm Inserter Connector,
Short (Catalog #14-441045) through the cannula of either the
Modular T-Handle, Non-Ratcheting (Catalog #29407) or Modular
After confirming the screw is retained to the insertion device,
proceed with inserting the screw into bone and continue placing
additional screws are needed.
Straight Handle, Ratcheting (Catalog #29408) and connect the
3.5mm Inserter, Short (Catalog #14-441046).
NOTE: When locking very distal screws, an attempt should be
made to countersink slightly, but not through the near cortex.
When inserting proximal screws, place the 3.5mm Inserter
Connector, Long (Catalog #14-441043) through the cannula of
either the Modular T-Handle, Non-Ratcheting (Catalog #29407) or
Modular Straight Handle, Ratcheting (Catalog #29408) and connect
the 3.5mm Inserter, Long (Catalog #14-441044).
During proximal screw insertion, line mark on the 3.5mm Inserter,
Long indicates when the screw head is fully seated (Ensure the
Soft Tissue Sleeve is firmly against bone).
Attach the appropriate screw to the threaded hex tip of the
Inserter Connector (Short or Long) and turn the knob in a
clockwise fashion.
NOTE: For final tightening 4mm screws and 5mm screws, the
3.5mm Solid Inserter-Long (Catalog #14-441051) or the 3.5mm
Solid Inserter-Short (Catalog #14-441052) should be used.
16
Step 12. Targeting Arm Assembly
Assemble the Tibial Nail Targeting Arm (Catalog #41000) to
the Driver Handle and secure with the Thumb Screw (Catalog
#41023).
17
Surgical Technique (Continued)
Step 13a. Proximal Locking - Static Screws
Assemble the Trocar (Catalog #41006) to the Drill Sleeve (Catalog
Insert the 4.3mm Calibrated Drill Bit (Catalog #41010) through
#41005) and insert through the Soft Tissue Sleeve (Catalog
the Drill Sleeve to perforate the medial cortex, pass through
#41004) through the Static hole (Dynamic Compression Slot) of
the nail and perforate the lateral cortex. With the Drill Sleeve
the Targeting Arm. Advance to the bone to determine and mark
assembly held firmly against the medial cortex, the appropriate
the entry point. Remove the Trocar and advance the assembly to
screw length is measured off the Calibrated Drill Bit, at the end of
the near cortex.
the Drill Sleeve. Alternatively, a Screw Depth Gauge (Extra Long)
(Catalog #14-442081) may be used to determine or verify the
Dynamic Compression Slot
length of the screw.
Note: All nail diameters utilize 5mm screws proximally.
Static
18
Step 13a. Proximal Locking - Static Screws (Continued)
The Drill Sleeve is removed and the appropriate 5mm screw
is inserted through the Soft Tissue Sleeve (reference pg. 16
for insertion detail). Ensure position of screw with radiographic
visualization. Be sure not to exceed more than 2mm in the far
cortex.
If desired, the Static screw can be locked with the preassembled,
embedded setscrew/locking mechanism. Insert the 4mm Hex
Driver (Catalog #41024) through the Driver Handle, into the
proximal aspect of the nail and turn in a clockwise motion.
19
Surgical Technique (Continued)
Step 13a. Proximal Locking - Static Screws (Continued)
An additional screw can be inserted in a similar fashion through
the Static hole of the Targeting Arm (reference pg. 16 for
insertion detail).
To remove the targeting assembly, insert the 5mm Connecting
Bolt Inserter through the Driver Handle to engage the connecting
bolt and turn counterclockwise to release attachment from the
nail.
20
Step 13b. Proximal Locking - Oblique Screws
The Drill Sleeve is removed and the appropriate 5mm screw
is inserted through the Soft Tissue Sleeve (reference pg. 16
for insertion detail). Ensure position of screw with radiographic
visualization. Be sure not to exceed more than 2mm in the far
cortex.
Assemble the Trocar (Catalog #41006) to the Drill Sleeve (Catalog
#41005) and insert through the Soft Tissue Sleeve (Catalog
Repeat this procedure for insertion of the second oblique screw.
#41004) through either the Distal Oblique or the Proximal Oblique
hole of the Targeting Arm. Advance to the bone to determine
and mark the entry point. Remove the Trocar and advance the
assembly to the near cortex.
Insert the 4.3mm Calibrated Drill Bit (Catalog #41010) through
the Drill Sleeve to perforate the medial cortex, pass through
the nail and perforate the lateral cortex. With the Drill Sleeve
assembly held firmly against the medial cortex, the appropriate
screw length is measured off the Calibrated Drill Bit, at the end of
the Drill Sleeve. Alternatively, a Screw Depth Gauge (Extra Long)
(Catalog #14-442081) may be used to determine or verify the
length of the screw.
Note: All nail diameters utilize 5mm screws proximally.
21
Surgical Technique (Continued)
Step 13b. Proximal Locking - Oblique Screws (Continued)
To remove the targeting assembly, insert the 5mm Connecting
Bolt Inserter through the Driver Handle to engage the connecting
bolt and turn counterclockwise to release attachment from the
nail.
When insertion of the proximal oblique screws are completed,
insert the 4mm Hex Driver through the Driver Handle into the
proximal aspect of the nail and turn in a clockwise motion to lock
the oblique screws with the preassembled, embedded setscrew/
locking mechanism. When complete, remove the hex driver.
22
Step 13c. Proximal Locking - Compression (Optional)
Dynamic Compression Slot
Dynamic
Assemble the Trocar (Catalog #41006) to the Drill Sleeve (Catalog
#41005) and insert through the Soft Tissue Sleeve (Catalog
#41004) through the Dynamic hole (Dynamic Compression Slot)
of the Targeting Arm. Advance to the bone to determine and mark
the entry point. Remove the Trocar and advance the assembly to
the near cortex.
The PhoenixTM Tibial Nail offers a preassembled, embedded
setscrew/locking mechanism that can provide up to 5mm of
compression.
Note: Mechanical compression may only be achieved through
the Dynamic hole and deployment of the preassembled,
Note: If compression is desired, first ensure distal locking
embedded setscrew/locking mechanism.
has been completed. Prior to compressing, remove the sleeve
assembly from bone.
23
Surgical Technique (Continued)
Step 13c. Proximal Locking - Compression (Optional)
Continued
Insert the 4.3mm Calibrated Drill Bit (Catalog #41010) through
the Drill Sleeve to perforate the medial cortex, pass through
the nail and perforate the lateral cortex. With the Drill Sleeve
assembly held firmly against the medial cortex, the appropriate
screw length is measured off the Calibrated Drill Bit, at the end of
the Drill Sleeve. Alternatively, a Screw Depth Gauge (Extra Long)
(Catalog #14-442081) may be used to determine or verify the
length of the screw.
The Drill Sleeve is removed and the appropriate 5mm screw
is inserted through the Soft Tissue Sleeve (reference pg. 16
for insertion detail). Ensure position of screw with radiographic
visualization. Be sure not to exceed more than 2mm in the far
cortex.
Note: All nail diameters utilize 5mm screws proximally.
24
Step 13c. Proximal Locking - Compression (Optional)
Continued
If using the preassembled setscrew for compression is desired,
insert the 4mm Hex Driver (Catalog #41024) through the
Driver Handle, into the proximal aspect of the nail and turn
in a clockwise motion. Monitor screw position and fracture
compression under radiographic visualization.
Alternatively, a backstroke technique can be employed for
compressing the fracture by using the Slotted Mallet in a reverse
manner under radiographic visualization monitoring.
25
Surgical Technique (Continued)
Step 13c. Proximal Locking - Compression (Optional)
Continued
After desired compression is achieved, repeat screw insertion
through the Static hole to support the achieved compression.
Upon screw insertion into the Static hole, use the 4mm Hex
Driver to reverse the preassembled setscrew (counterclockwise)
until it stops against the Connecting Bolt. This will ensure correct
positioning of the preassembled setscrew for locking the proximal
oblique screws, if desired.
26
Step 13c. Proximal Locking - Compression (Optional)
Continued
To remove the targeting assembly, insert the 5mm Connecting
Bolt Inserter through the Driver Handle to engage the connecting
bolt and turn counterclockwise to release attachment from the
nail.
When insertion of the proximal oblique screws are completed,
insert the 4mm Hex Driver through the Driver Handle into the
proximal aspect of the nail and turn in a clockwise motion to lock
the oblique screws with the preassembled, embedded setscrew/
locking mechanism. When complete, remove the hex driver.
27
Introduction
Step 14. Distal Locking
Verify the depth of the nail distally in both A/P and lateral views.
The PhoenixTM Tibial Nail may be locked distally with screws in
both the sagittal and frontal planes. Distal A/P locking allows for
placement of perpendicular screws for a more secure fixation of
the distal fragment.
When treating distal third fractures, ensure at a minimum, two
distal locking screws are used below the fracture site.
A/P View
NOTE: When locking from anterior to posterior all instruments
M/L View
placed to the bone should be done medial to the tibialis anterior
tendon. The tendon should be retracted laterally to allow safe
placement of the locking screw.
Distal locking may be accomplished using a freehand technique
or by using the Biomet® Radiolucent Targeting Device. The
image intensifier is aligned with the more distal hole in the nail,
such that the hole appears as a perfect circle. A knife blade is
placed on the skin, with the incision point verified on the image
intensifier, and a 1cm incision is made over the hole in the nail.
The tip of the drill bit appears as a solid circle in the center of the
screw hole. Proceed to drill through both cortices. The position of
the drill bit is confirmed on the image intensifier in both the A/P
and Lateral planes, before it is withdrawn. Additional screw holes
are drilled in a similar fashion.
Perfect Circle
NOTE: Distally, a 3.2mm drill bit is used for 4mm screws with the
7.5mm nails only and a 4.3mm drill bit is used for 5mm screws
with 9mm or larger nails.
Incorrect
NOTE: For final tightening 4mm screws and 5mm screws, the
3.5mm Solid Inserter-Long (Catalog #14-441051) or the 3.5mm
Solid Inserter-Short (Catalog #14-441052) should be used.
28
End Cap Insertion
If desired, one of five different profile end caps ranging from
0mm to 20mm (available in 5mm increments) can be inserted
into the proximal end of the PhoenixTM Tibial Nail to prevent bony
in-growth. For insertion, thread the end cap to the insertion device,
in similar fashion for screw insertion (as referenced on pg. 16).
0mm
5mm
10mm
15mm
20mm
NOTE: For final tightening end caps, the 3.5mm Solid InserterLong (Catalog #14-441051) or the 3.5mm Solid Inserter-Short
(Catalog #14-441052) should be used.
29
Surgical Technique (Continued)
Nail Removal
Remove the end cap if implanted and all but one of the locking
screws with the 3.5mm Inserter Connector. It is important to leave
one screw in the nail to prevent nail rotation when connecting
the nail extractor to the nail. Alternatively, if all screws have been
removed a 4.3mm Drill Bit can be placed through any of the
removed screw holes. If needed, the 3.5mm Hex Screw Extractor*
(Catalog #14-442084) may be used to remove either a 4mm or
5mm screw.
Insert a Guide Wire into the top of the nail to help guide the
extractor to the proximal portion of the nail. Attach the 3/4”
Driver (Catalog #14-442066) to the Nail Extractor Tap* (Catalog
#14-441048) and thread the assembly into the top of the nail. A
tight interference fit should be achieved. The extractor is meant
to cross-thread into the proximal portion of the nail. Thread the
Slap Hammer Shaft (Catalog #29448) into the Nail Extractor Tap
and remove the remaining screw or drill bit. Extract the nail with a
backslapping motion using the Slotted Mallet.
Note: Since the holes within the embedded setscrew are grooved,
proximal screw removal can be achieved without disengaging the
embedded setscrew.
*Available sterile packed
30
Product Ordering Information
7.5mm Tibial Nails
9mm Tibial Nails (cont’d)
Catalog#Description
Catalog#Description
40024
Tibial Nail, 7.5mm x 240mm
40337
Tibial Nail, 9mm x 370mm
40025
Tibial Nail, 7.5mm x 250mm
40338
Tibial Nail, 9mm x 380mm
40026
Tibial Nail, 7.5mm x 260mm
40339
Tibial Nail, 9mm x 390mm
40027
Tibial Nail, 7.5mm x 270mm
40340
Tibial Nail, 9mm x 400mm
40028
Tibial Nail, 7.5mm x 280mm
40341
Tibial Nail, 9mm x 410mm
40029
Tibial Nail, 7.5mm x 290mm
40342
Tibial Nail, 9mm x 420mm
40030
Tibial Nail, 7.5mm x 300mm
10.5mm Tibial Nails
40031
Tibial Nail, 7.5mm x 310mm
Catalog#Description
40032
Tibial Nail, 7.5mm x 320mm
40033
Tibial Nail, 7.5mm x 330mm
40034
Tibial Nail, 7.5mm x 340mm
40035
Tibial Nail, 7.5mm x 350mm
40036
Tibial Nail, 7.5mm x 360mm
40037
Tibial Nail, 7.5mm x 370mm
40038
Tibial Nail, 7.5mm x 380mm
40039
Tibial Nail, 7.5mm x 390mm
40040
Tibial Nail, 7.5mm x 400mm
40041
Tibial Nail, 7.5mm x 410mm
40042
Tibial Nail, 7.5mm x 420mm
40624
Tibial Nail, 10.5mm x 240mm
40625
Tibial Nail, 10.5mm x 250mm
40626
Tibial Nail, 10.5mm x 260mm
40627
Tibial Nail, 10.5mm x 270mm
40628
Tibial Nail, 10.5mm x 280mm
40629
Tibial Nail, 10.5mm x 290mm
40630
Tibial Nail, 10.5mm x 300mm
40631
Tibial Nail, 10.5mm x 310mm
40632
Tibial Nail, 10.5mm x 320mm
40633
Tibial Nail, 10.5mm x 330mm
40634
Tibial Nail, 10.5mm x 340mm
9mm Tibial Nails
40635
Tibial Nail, 10.5mm x 350mm
Catalog#Description
40636
Tibial Nail, 10.5mm x 360mm
40324
Tibial Nail, 9mm x 240mm
40637
Tibial Nail, 10.5mm x 370mm
40325
Tibial Nail, 9mm x 250mm
40638
Tibial Nail, 10.5mm x 380mm
40326
Tibial Nail, 9mm x 260mm
40639
Tibial Nail, 10.5mm x 390mm
40327
Tibial Nail, 9mm x 270mm
40640
Tibial Nail, 10.5mm x 400mm
40328
Tibial Nail, 9mm x 280mm
40641
Tibial Nail, 10.5mm x 410mm
40329
Tibial Nail, 9mm x 290mm
40642
Tibial Nail, 10.5mm x 420mm
40330
Tibial Nail, 9mm x 300mm
40331
Tibial Nail, 9mm x 310mm
40332
Tibial Nail, 9mm x 320mm
40333
Tibial Nail, 9mm x 330mm
40334
Tibial Nail, 9mm x 340mm
40335
Tibial Nail, 9mm x 350mm
40336
Tibial Nail, 9mm x 360mm
31
Product Ordering Information (Continued)
12mm Tibial Nails
13.5mm Tibial Nails
Catalog#Description
Catalog#Description
40924
Tibial Nail, 12mm x 240mm
14-441224
Tibial Nail, 13.5mm x 240mm
40925
Tibial Nail, 12mm x 250mm
14-441225
Tibial Nail, 13.5mm x 250mm
40926
Tibial Nail, 12mm x 260mm
14-441226
Tibial Nail, 13.5mm x 260mm
40927
Tibial Nail, 12mm x 270mm
14-441227
Tibial Nail, 13.5mm x 270mm
40928
Tibial Nail, 12mm x 280mm
14-441228
Tibial Nail, 13.5mm x 280mm
40929
Tibial Nail, 12mm x 290mm
14-441229
Tibial Nail, 13.5mm x 290mm
40930
Tibial Nail, 12mm x 300mm
14-441230
Tibial Nail, 13.5mm x 300mm
40931
Tibial Nail, 12mm x 310mm
14-441231
Tibial Nail, 13.5mm x 310mm
40932
Tibial Nail, 12mm x 320mm
14-441232
Tibial Nail, 13.5mm x 320mm
40933
Tibial Nail, 12mm x 330mm
14-441233
Tibial Nail, 13.5mm x 330mm
40934
Tibial Nail, 12mm x 340mm
14-441234
Tibial Nail, 13.5mm x 340mm
40935
Tibial Nail, 12mm x 350mm
14-441235
Tibial Nail, 13.5mm x 350mm
40936
Tibial Nail, 12mm x 360mm
14-441236
Tibial Nail, 13.5mm x 360mm
40937
Tibial Nail, 12mm x 370mm
14-441237
Tibial Nail, 13.5mm x 370mm
40938
Tibial Nail, 12mm x 380mm
14-441238
Tibial Nail, 13.5mm x 380mm
40939
Tibial Nail, 12mm x 390mm
14-441239
Tibial Nail, 13.5mm x 390mm
40940
Tibial Nail, 12mm x 400mm
14-441240
Tibial Nail, 13.5mm x 400mm
40941
Tibial Nail, 12mm x 410mm
14-441241
Tibial Nail, 13.5mm x 410mm
40942
Tibial Nail, 12mm x 420mm
14-441242
Tibial Nail, 13.5mm x 420mm
32
4mm Double-Lead Thread Screws
5mm Double-Lead Thread Screws
Catalog#Description
Catalog#Description
14-400420
4mm x 20mm screw
14-405020
5mm x 20mm screw
14-400422
4mm x 22mm screw
14-405022
5mm x 22mm screw
14-400424
4mm x 24mm screw
14-405024
5mm x 24mm screw
14-400426
4mm x 26mm screw
14-405026
5mm x 26mm screw
14-400428
4mm x 28mm screw
14-405028
5mm x 28mm screw
14-400430
4mm x 30mm screw
14-405030
5mm x 30mm screw
14-400432
4mm x 32mm screw
14-405032
5mm x 32mm screw
14-400434
4mm x 34mm screw
14-405034
5mm x 34mm screw
14-400436
4mm x 36mm screw
14-405036
5mm x 36mm screw
14-400438
4mm x 38mm screw
14-405038
5mm x 38mm screw
14-400440
4mm x 40mm screw
14-405040
5mm x 40mm screw
14-400442
4mm x 42mm screw
14-405042
5mm x 42mm screw
14-400444
4mm x 44mm screw
14-405044
5mm x 44mm screw
14-400446
4mm x 46mm screw
14-405046
5mm x 46mm screw
14-400448
4mm x 48mm screw
14-405048
5mm x 48mm screw
14-400450
4mm x 50mm screw
14-405050
5mm x 50mm screw
14-400452
4mm x 52mm screw
14-405052
5mm x 52mm screw
14-400454
4mm x 54mm screw
14-405054
5mm x 54mm screw
14-400456
4mm x 56mm screw
14-405056
5mm x 56mm screw
14-400458
4mm x 58mm screw
14-405058
5mm x 58mm screw
14-405060
5mm x 60mm screw
14-405065
5mm x 65mm screw
14-405070
5mm x 70mm screw
14-405075
5mm x 75mm screw
14-405080
5mm x 80mm screw
14-405085
5mm x 85mm screw
14-405090
5mm x 90mm screw
14-405095
5mm x 95mm screw
14-405100
5mm x 100mm screw
14-405105
5mm x 105mm screw
14-405110
5mm x 110mm screw
33
Product Ordering Information (Continued)
End Caps
Disposables
Catalog#Description
Catalog#Description
14-441280
End Cap, 0mm
27914
14-441281
End Cap, 5mm
27984
4.3mm x 152mm Short Drill Bit
2
14-441282
End Cap, 10mm
41009
One-Step Reamer, 11.5mm
1
14-441283
End Cap, 15mm
41010
4.3mm x 320mm Calibrated Drill Bit
2
14-441284
End Cap, 20mm
467210
3.2mm x 80cm Nail Driving Guide
2
3.2mm x 460mm Entry Guide Wire
Qty
2
471133
3.2mm x 355mm Entry Guide Wire
2
471830
Radiolucent Targeting Device
1
471835
3.2mm Radiolucent Targeting Device Twist Drill
1
471843
4.3mm Radiolucent Targeting
Device Twist Drill
1
472060
3.2mm x 180mm Calibrated Drill Bit
2
14-410002
2.6mm x 80cm Bead Tip Guide Wire
2
34
Instruments
Instruments (Continued)
Catalog#Description
27940
52cm Ni-Ti Reamer Shaft
Qty
Catalog#Description
1
595400
Tibial Nail Instrument Tray (empty)
Qty
1
27958
40cm Ni-Ti Reamer Shaft
1
14-400082
Tibial Nail Instrument Tray (fully kitted)
27977
Stryker/AO Power Adapter
1
14-440047
Telescoping Nail Measuring Gauge
1
29407
Modular T-Handle, Non-Ratcheting
1
14-441043
3.5mm Inserter Connector, Long
1
29408
Modular Straight Handle, Ratcheting
1
14-441044
3.5mm Inserter, Long
1
29448
Slap Hammer Shaft
1
14-441045
3.5mm Inserter Connector, Short
1
41000
Tibial Nail Targeting Arm
1
14-441046
3.5mm Inserter, Short
1
41001
Slap Hammer Adapter
1
14-441047
Impactor Cap
1
41002
Connecting Bolt Driver
2
14-441048
Nail Extractor Tap*
1
41003
5mm Connecting Bolt Inserter
1
14-441051
3.5mm Solid Inserter, Long
1
41004
Soft Tissue Sleeve
2
14-441052
3.5mm Solid Inserter, Short
1
41005
Drill Sleeve
2
14-442053
Slotted Mallet
1
2
14-442066
3/4” Hex Driver
1
41006Trocar
41018
Driver Handle
1
14-442068
8.5mm Fracture Reducer (Bowed)
1
41023
Thumb Screw
2
14-442073
Pseudarthrosis Pin Straight
1
41024
4mm Hex Driver
1
14-442074
Pseudarthrosis Pin Curved
1
41026
Curved Cannulated Awl
1
14-442075
Medullary Canal and Length Estimator
1
41027
Wire Pusher
1
14-442076
Short 4.3mm Drill Measuring Sleeve
1
41029
Working Channel Soft Tissue Sleeve
1
14-442078
Keyless Chuck T-Handle
1
467534
8.0mm Reamer Head
1
14-442081
Screw Depth Gauge (Extra Long)
1
467536
8.5mm Reamer Head
1
14-442082
Screw Depth Gauge (Extra Short)
1
467538
9.0mm Reamer Head
1
14-442084
3.5mm Hex Screw Extractor*
1
467540
9.5mm Reamer Head
1
14-442085
8.5mm Fracture Reducer Straight
1
467542
10.0mm Reamer Head
1
14-442089
Hall/Stryker Power Adapter
1
467544
10.5mm Reamer Head
1
14-442098
Entry Trocar
1
467546
11.0mm Reamer Head
1
467548
11.5mm Reamer Head
1
467550
12.0mm Reamer Head
1
467552
12.5mm Reamer Head
1
467554
13.0mm Reamer Head
1
467556
13.5mm Reamer Head
1
467558
14.0mm Reamer Head
1
467560
14.5mm Reamer Head
1
* Available sterile packed
35
Phoenix™ Tibial Nail System Package Insert
Biomet Trauma
56 East Bell Drive
P.O. Box 587
Warsaw, Indiana 46581 USA
01-50-4005
Rev.A
Date: 2012-06
®
Biomet Intramedullary Nail Implants
ATTENTION OPERATING SURGEON
DESCRIPTION
Biomet® manufactures a variety of titanium intramedullary nails
intended to aid in the alignment and stabilization of fractures of
bones in the skeletal system, in the skeletal system, and to aid
in reconstructive surgery. Implant components used for these
applications include: intramedullary nails, screws, and end caps.
Osseotite screws may also be used with the Peritrochanteric
Nail System.
MATERIALS
Titanium Alloy
UHMWPE
INDICATIONS
Phoenix Tibial Nail System
The Phoenix Tibial Nail System is indicated for alignment,
stabilization, and fixation of fractures caused by trauma or disease,
and the fixation of long bones that have been surgically prepared
(osteotomy) for correction of deformity and for arthrodesis.
CONTRAINDICATIONS
1. Infection.
2. Patient conditions including blood supply limitations, and
insufficient quantity or quality of bone.
3. Patients with mental or neurologic conditions who are
unwilling or incapable of following postoperative care
instructions.
4. Foreign body sensitivity. Where material sensitivity is suspected,
testing is to be completed prior to implantation of the device.
WARNINGS
Internal fixation devices aid the surgeon in the alignment
and stabilization of skeletal fractures and provide a means of
fracture management in reconstructive surgical applications.
While these devices are generally successful in attaining these
goals, they cannot be expected to replace normal healthy bone or
withstand the stress placed upon the device by full or partial weight
bearing or load bearing, particularly in the presence of nonunion,
delayed union, or incomplete healing. Metallic bone fixation
devices are internal splints that align the fracture until normal
healing occurs. The size and shape of bones and soft tissue
place limitations on the size and strength of implants.
If there is delayed union or nonunion of bone in the presence
of weight bearing, or load bearing, the implant could eventually
break. Therefore, it is important that immobilization (use of
external support, walking aids, braces, etc.) of the fracture site
be maintained until firm bony union (confirmed by clinical and
radiographic examination) is established. Surgical implants are
subject to repeated stresses in use, which can result in fatigue
fracture. Factors such as the patient’s weight, activity level, and
adherence to weight bearing or load bearing instructions have
an effect on the service life of the implant. The surgeon must be
thoroughly knowledgeable not only in the medical and surgical
aspects of the implant, but also must be aware of the mechanical
and metallurgical aspects of the surgical implants. Bone screws,
3mm – 10mm in diameter and 10mm – 75mm in overall length
are not approved for screw attachment or fixation to the posterior
elements (pedicles) of the cervical, thoracic or lumbar spine.
1. Correct selection of the implant is extremely important. The
potential for success in fracture fixation is increased by the
selection of the proper type of implant. While proper selection
can help minimize risks, the size and shape of human bones
present limitations on the size and strength of implants.
Internal fixation devices cannot withstand the activity levels
and/or loads equal to those placed on normal healthy bone.
These devices are not designed to withstand the unsupported
stress of full weight bearing, or load bearing.
2. The devices can break when subjected to increased loading
associated with nonunion or delayed union. Internal fixation
devices are load-sharing devices that hold a fracture in
alignment until healing occurs. If healing is delayed, or does
not occur, the implant can be expected to break, bend or fail.
Loads produced by weight bearing, and activity levels may
dictate the longevity of the implant.
3. Implant materials are subject to corrosion. Implanting metals
and alloys subjects them to constant changing environments
of salts, acids, and alkalis that can cause corrosion. Putting
dissimilar metals and alloys in contact with each other can
accelerate the corrosion process that may enhance fracture
of implants. Every effort should be made to use compatible
metals and alloys when marrying them to a common goal, i.e.,
screws and plates.
36
4. Correct handling of implants is extremely important. Do not
modify implants. Do not notch or bend implants. Notches or
scratches put in the implant during the course of surgery may
contribute to breakage. Intraoperative fracture of screws can
occur if excessive force (torque) is applied while seating bone
screws.
5. Remove after fracture has healed. Implants can loosen,
fracture, corrode, migrate, or cause pain. If an implant remains
implanted after complete healing, the implant may cause
stress shielding, which may increase the risk of, refracture
in an active patient. The surgeon should weigh the risks
verses benefits when deciding whether to remove the implant.
Adequate postoperative management to avoid refracture
should follow implant removal.
6. Adequately instruct the patient. Postoperative care is important.
The patient’s ability and willingness to follow instruction is
one of the most important aspects of successful fracture
management. Patients with senility, mental illness, alcoholism,
and drug abuse may be at higher risk. These patients may
ignore instructions and activity restrictions. The patient is to
be instructed in the use of external supports, walking aids,
and braces that are intended to immobilize the fracture site
and limit weight bearing or load bearing. The patient is to be
made fully aware and warned that the device does not replace
normal healthy bone, and that the device can break, bend or
be damaged as a result of stress, activity, load bearing, or
weight bearing. The patient is to be made aware and warned
of general surgical risks, possible adverse effects, and to
follow the instructions of the treating physician. The patient is
to be advised of the need for regular postoperative follow-up
examination as long as the device remains implanted.
7. Nails with a diameter of 9mm or less are intended for use in
pediatric patients. Do not use these sizes in teenage or adult
patients. The size and strength of these nails is inadequate for
loads experienced with teenage or adult patients. Laboratory
testing demonstrates that 8mm and 9mm diameter nails have
a fatigue life approximately one-fourth that of 12mm nails.
Where possible, use 12mm or larger diameter nails. In cases
where a small nail size was used, the surgeon may want to
consider replacing the small nail with a larger nail after
three months.
8. To reduce the driving force on the nail and the potential risk of
nail damage, the physician should consider reaming 1/2mm to
1 1/2mm larger than the nail implanted.
9. Do not implant a nail with the distal holes or proximal holes
at or within the fracture line. If nail is implanted with distal or
proximal holes in the fracture line, effective screw fixation will
be compromised which may lead to breakage or bending of
the implant.
10. Difficult tibial fractures may take 8 to 12 months to heal.
Treat with caution due to the extended healing time. When
nonreaming techniques are used or when smaller diameter
nails are used, the surgeon should consider one or more of the
following treatments:
a) Graft the tibial fracture site at time of surgery.
b) Remove screws proximally or distally at 2 to 3 months.
c) Exchange the tibial nail for a larger diameter tibial nail at
3 to 4 months.
11. Patient smoking may result in delayed healing, non-healing
and/or compromised stability in or around the placement site.
PRECAUTIONS
Device is single use only.
Do not reuse implants. While an implant may appear undamaged,
previous stress may have created imperfections that would
reduce the service life of the implant.
Do not treat patients with implants that have been even
momentarily placed in a different patient.
Instruments are available to aid in the accurate implantation of
internal fixation devices. Intraoperative fracture or breaking of
instruments has been reported.
Surgical instruments are subject to wear with normal usage.
Instruments, which have experienced extensive use or excessive
force, are susceptible to fracture. Surgical instruments should
only be used for their intended purpose. Biomet recommends that
all instruments be regularly inspected for wear and disfigurement.
POSSIBLE ADVERSE EFFECTS
1. Nonunion or delayed union, which may lead to breakage of the
implant.
2. Bending or fracture of the implant.
3. Loosening or migration of the implant.
4. Metal sensitivity, or allergic reaction to a foreign body.
5. Limb shortening due to compression of the fracture or bone
resorption.
6. Decrease in bone density due to stress shielding.
7. Pain, discomfort, or abnormal sensation due to the presence of
the device.
8. Nerve damage due to surgical or preexisting trauma.
9. Necrosis of bone.
10. Postoperative bone fracture and pain.
11. Inadequate healing.
12 Early or late postoperative infection and allergic reaction.
37
Phoenix™ Tibial Nail System Package Insert (Continued)
MAGNETIC RESONANCE (MR) STATEMENT
The effects of the MR environment have not been determined
for this device. This device has not been tested for heating or
migration in the MR environment.
STERILITY
Biomet Intramedullary Nail implants are provided sterile and
clearly marked “STERILE” on the packaging. These implants have
been sterilized using a minimum dosage of 2.5 megaRad (25 kGy)
of gamma radiation. Where specified, do not use implants after
expiration date.
CAUTION: Federal law (USA) restricts this device to sale by or on
the order of a physician.
Comments regarding this device can be directed to Attn:
Regulatory Dept., Biomet, Inc., P.O. Box 587, Warsaw, IN 46582
USA, Fax: 574-372-3968.
All trademarks herein are the property of Biomet, Inc. or its
subsidiaries unless otherwise indicated.
CE Mark on the package insert (IFU) is not valid unless there is a
CE Mark on the product (description) label.
Authorized Representative: Biomet U.K., Ltd.
Waterton Industrial Estate
Bridgend, South Wales
CF31 3XA UK
38
Further Information
This brochure describes a surgical technique used by Michael
For further information, please contact the Customer Service
S. Sirkin, M.D., Cory A. Collinge, M.D. and Kenneth J. Koval,
Department at:
M.D. The surgeon who performs any implant procedure
is responsible for determining the appropriate products(s)
Biomet Trauma
and utilizing technique(s) for in each individual patient. The
56 East Bell Drive
contents of this manual are intended to be only a guide and
P.O. Box 587
are not intended to set a standard of care.
Warsaw, Indiana 46581-0587
800.348.9500 x 1501
www.biomet.com
39
Notes:
40