PL
PILON LOCKING PLATE small
emergency team for broken bones®
optional locking - non
locking in shaft
smaller design
locking between screws
and plate
optimal reconstruction of
the joint
PILON PLATE small
emergency team for broken bones®
37351-XX-N
Cortical Screw, locking, D=3.5mm, SH
61273-100
Spiral Drill, D=2.7mm, L=100mm, AO Connector
56252
Screwdriver, WS 2.5,
with self-holding sleeve
32351-XX
Cortical Screw, D=3.5mm
61273-100
Spiral Drill, D=2.7mm, L=100mm, AO Connector
56252
Screwdriver, WS 2.5,
with self-holding sleeve
37422-XX-N
Cancellous Screw, locking, D=4.2mm, SH
61253-180
Spiral Drill, D=2.5mm, L=180mm, AO Connector
56252
Screwdriver, WS 2.5,
with self-holding sleeve
02 i.t.s.
Features
Features
Implant:
Material:
• Multidirectional Locking
• Optimal reconstruction of the
joint
• Free choice of screw angle
• Ø 3.5 mm Cortical Screws
• Ø 4.2 mm locking Cancellous
Screws
• Anatomically contoured
• Plate lengths: 4, 6, 8 - hole
• Plate material: Titanium
• Screw material: TiAl6V4 ELI
• Easy removal of the implant after fracture healing
• Increased fatigue strenth of the implants
• Decreased addiction to cold bonding
• Decreased risk of infection and allergy
locking
PILON PLATE
All I.T.S. locking plates are anatomically pre-contoured. In the unlikely event that the plate has to be formed to the bone
please notice that slight contouring is possible.
ATTENTION: Significant bending at the locking holes will reduce locking effectiveness and if bend more than once in both
directions it might weaken the titanium plate strongly.
i.t.s.
03
Locking Pilon Plate
for the treatment of complex
fractures of the tibial pilon
Fractures of the tibial pilon of AO
classification C2 and C3 present a
serious problem for the reposition
of the fracture, and especially
for stabilisation of the reposition
results until healing has occurred.
Collapsing of comminuted zones
or partial lysis of corticospongiosal
chips or spongiosa often lead to
defective positions in the upper
ankle joint despite exact primary
reposition.
For this reason we developed
an locking Pilon Plate in 2002.
It consists of titanium, has a low
profile height and is anatomically
contoured in the distal area.
The angular stability is achieved
by displacing harder screws in the
plate.
The screws can be set in not only
at 90° but also up to 15° deviation.
PILON PLATE small
emergency team for broken bones®
04 i.t.s.
Indications
Contraindications
• Fractures of the tibial pilon of
AO classification A3, especially
groups C2 and C3.
• Very advanced osteoporosis with
very soft bones
• Skin and soft-tissue problems
which prevent a tension-free
closure of the skin
Path of access
1.) medial skin incision or stab
incision or small auxiliary
incisions.
2.) reposition and reconstruction
of joint unit by means of the
small medial skin incision or
percutaneously or by small
auxiliary incisions. Fixation
using small-fragment screws
or drill wires; fill defects using
corticospongiosal chips or
bone substitute.
3.) manoeuvre the pilon plate over
the medial skin incision.
4.) fasten the pilon plate onto the
tibial shaft percutaneously using
cortex screws.
5.) reposition the joint unit onto
the pilon plate and fasten using
stable-angle screws.
6.) skin closure using tension-free
single button sutures.
Postoperativ
Elastic bandage and no stress
according to fracture for between
8 and 12 weeks.
After swelling has subsided,
physiotherapy should be started.
Time of operation
• Primarily: in the first hour after
trauma
• Secondarily: after swelling has
subsided; intermediate fixation
by means of a external fixator or
by means of extension.
locking
PILON PLATE
Surgical technique
Under a general anaesthetic
or regional anaesthetic with
pneumatic partial deprivation of
blood supply.
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05
Results
Up to now, persons treated with
locking Pilon Plates have been
men between the ages of 29 and
50. These include both fresh pilon
fractures and corrections after
deformed healed fractures.
The fresh fractures were all C3
fractures, and the corrections were
C3- and A2- fractures after primary
treatment with locking pin.
In all cases closure of the wound
was achieved and primary healing
took place.
The cases which we have
observed up to now have shown
no change of reposition results
or correction results up to bony
consolidation, which occurred
between 8 and 12 weeks
postoperatively
Up to the point of healing of bony
tissue, free or almost free mobility
was achieved in all cases.
PILON PLATE small
emergency team for broken bones®
Summary
The locking Pilon Plate is a minimally invasive implant for complex
fractures of the pilon with intact skin and soft-tissue state.
It enables mobilisation-stable fixation and with the help of early exercise
therapy leads to good or excellent results.
06 i.t.s.
Case Studies
locking
PILON PLATE
i.t.s.
07
Implants & Instruments
PILON PLATE small
emergency team for broken bones®
Order No.
1
Pilon Plate, Small, 4-Hole
21093-4
2
Pilon Plate, Small, 6-Hole
21093-6
3
Pilon Plate, Small, 8-Hole
21093-8
4
Cortical Screw, D=3.5mm, L=24mm
32351-24
Cortical Screw, D=3.5mm, L=28mm
32351-28
Cortical Screw, D=3.5mm, L=32mm
32351-32
Cortical Screw, D=3.5mm, L=36mm
32351-36
Cortical Screw, D=3.5mm, L=40mm
32351-40
5
6
08
i.t.s.
Cortical Screw, Locking, D=3.5mm, L=24mm, SH
37351-24-N
Cortical Screw, Locking, D=3.5mm, L=28mm, SH
37351-28-N
Cortical Screw, Locking, D=3.5mm, L=32mm, SH
37351-32-N
Cortical Screw, Locking, D=3.5mm, L=36mm, SH
37351-36-N
Cortical Screw, Locking, D=3.5mm, L=40mm, SH
37351-40-N
Cancellous Screw, Locking, D=4.2mm, L=18mm, SH
37422-18-N
Cancellous Screw, Locking, D=4.2mm, L=20mm, SH
37422-20-N
Cancellous Screw, Locking, D=4.2mm, L=22mm, SH
37422-22-N
Cancellous Screw, Locking, D=4.2mm, L=24mm, SH
37422-24-N
1
2
6
3
4
11
12
8
10
5
9
7
13
locking
PILON PLATE
Cancellous Screw, Locking, D=4.2mm, L=26mm, SH
37422-26-N
Cancellous Screw, Locking, D=4.2mm, L=28mm, SH
37422-28-N
Cancellous Screw, Locking, D=4.2mm, L=30mm, SH
37422-30-N
Cancellous Screw, Locking, D=4.2mm, L=32mm, SH
37422-32-N
Cancellous Screw, Locking, D=4.2mm, L=34mm, SH
37422-34-N
Cancellous Screw, Locking, D=4.2mm, L=36mm, SH
37422-36-N
Cancellous Screw, Locking, D=4.2mm, L=38mm, SH
37422-38-N
Cancellous Screw, Locking, D=4.2mm, L=40mm, SH
37422-40-N
i.t.s.
09
Implants & Instruments
PILON PLATE small
emergency team for broken bones®
10
i.t.s.
Cancellous Screw, Locking, D=4.2mm, L=42mm, SH
37422-42-N
Cancellous Screw, Locking, D=4.2mm, L=44mm, SH
37422-44-N
Cancellous Screw, Locking, D=4.2mm, L=46mm, SH
37422-46-N
Cancellous Screw, Locking, D=4.2mm, L=48mm, SH
37422-48-N
Cancellous Screw, Locking, D=4.2mm, L=50mm, SH
37422-50-N
7
Screw Driver, WS 2.5, Self Holding Sleeve
56252
8
Depth Gauge, Solid Small Fragment Screws
59022
9
Spiral Drill, D=2.5mm, L=180 mm, AO Connector
61253-180
10
Spiral Drill, D=2.7mm, L=100 mm, AO Connector
61273-100
11
Drill Guide, D=2.7/2.0mm
62202
12
Cortical Counter Sink, with Stop support
63404
13
Sterilization Tray, Pilon Plate
50187
1
2
6
3
4
11
12
8
10
5
9
7
13
locking
PILON PLATE
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11
LOCKING
Locking works because of:
• Screw material (TiAlV) is slightly harder than plate
material (Titanium Grade 2)
• Screw head forms thread into the plate (no cutting)
Benefits:
•
•
•
•
•
± 15° and Locking
No pre threading
No cold welding
No debris
Re-setting of screw (up to 3 times)
30°
®
DOTIZE
Chemical process - anodization in a strong alkaline solution *
Type III anodization
Dotize
Type II anodization
Layer thickness 60-200nm
Layer thickness 2000-10 000nm
+
Different colors
+
Film become an interstitial part of the titanium
-
Implant surface remains sensitive to:
Chipping
Peeling
Discoloration
-
No visible cosmetical effect
Anodization Type II leads to following benefits *
•
•
•
•
•
•
•
•
12
i.t.s.
Oxygen and silicon absorbing conversion layer
Decrease in protein adsorption
Closing of micro pores and micro cracks
Reduced risk of inflammation and allergy
Hardened titanium surface
Reduced tendency of cold welding of titanium implants
Increased fatigue resistance of implants
Improved wear and friction characteristics
* White Paper: Ti6Al4V with Anodization Type II: Biological Behavior and Biomechanical Effects; Axel Baumann, Nils Zander
Notes:
i.t.s.
13
Sterilization Guidelines
The following remarks should serve as a guideline in the sterilization of medical
products.
IMPORTANT INDICATIONS FOR DOCTORS AND
OPERATING THEATRE PERSONNEL
This instruction leaflet refers to all supplied nonsterile implants and all reusable instruments
from I.T.S. GmbH. Detailed information for the
identification of the product (such as system
classification, cat. no.) can be found in the product
identification code and/ or on the package label.
Make sure that you are familiar with the possibilities
of application, combinability and correct handling
of the product. Please note that product systems
can undergo modifications which can affect the
combinability of the implant with other implants
or instruments. Detailed user information can be
found in the respective surgical instructions.
Intended Use of the Implant
The implant temporarily stabilises bone segments
until bony consolidation has taken place. After
this, the implant has no more use and can be
removed.
Indications and Contra-Indications of the Implant
Indications and contra-indications are determined
by current medical practice.
Side Effects of the Implant
Up to now, no allergic reactions have been known
with titanium implants. Allergic reactions to steel
implants cannot be excluded.
Warnings and Preventive Measures
• Pay attention to the instructions on the package.
• Implants are only to be used once.
• Always treat implants carefully to avoid surface
damage or geometric alterations.
• Any alterations to the design of implants of I.T.S.
GmbH are prohibited.
• Regular postoperative follow-up examinations
(e.g. X-ray check-ups) are to be carried out.
• For metallurgical, mechanical and design reasons,
never combine implants from different producers.
Materials used are stated in the product catalogue
or on the label.
• The length, angle and right or left version of an
implant of a particular type can differ.
• The precise positioning and fastening of a
properly made connection between implant and
instrument must be repeatedly checked during the
course of an operation.
14
i.t.s.
• In the case of magnetic resonance imaging
(MRI), it is generally recommended to check back
with the manufacturer of the MR scanner. The use
of MRI with steel implants is prohibited by I.T.S.
GmbH, and in such cases the user must contact
the manufacturer of the MRI scanner.
• Staff who come into contact with contaminated
or potentially contaminated medical products
should follow the generally recognised preventive
measures. Due care is to be taken when handling
medical products with sharp points or edges.
• Appropriate protective measures must be
taken to ensure safe handling when dealing with
contaminated or potentially contaminated medical
products (e.g. gloves, etc.)
• In countries with stricter safety requirements
regarding recycling medical products, these safety
requirements apply and are to be adhered to.
• Supplied non-sterile medical products must be
thoroughly prepared according to these instructions
before use.
• No metal brushes or abrasive cleaning materials
are to be used for manual cleaning purposes.
The use of these materials can lead to damage of
surfaces and coatings. Instead, soft brushes made
of nylon should be used.
• Steam (damp heat) is the recommended
sterilization method of medical products of I.T.S.
GmbH.
• All the following described steps for cleaning and
sterilization are made easier when contaminants
(e.g. blood) are not allowed to dry beforehand.
Restrictions
• Unless otherwise stated, repeated preparation of
re-usable instruments of I.T.S. GmbH has minimal
effects on them when following the procedures
mentioned below.
• The end of the product service life is usually
determined by wear and damage caused by use.
• Instruments containing aluminium or anodised
aluminium are damaged by alkaline (pH > 7)
cleaning agents and solutions.
INSTRUCTIONS FOR RECONDITIONING
Preparation at the Location of Use
• Remove surface dirt using a disposable cloth or
paper towel.
Storage and Transport
• No special requirements.
• It is recommended to recondition medical products
as soon as possible after their previous use.
Cleaning/ Disinfection/ Drying
Cleaning automatic
Recommended equipment: commercially available
disinfector authorized for use with medical
products, with tested efficiency; commercially
available cleaning agent authorized for use with
medical products (alkaline – with pH value < 11).
Step 1 Each instrument that can be dismantled
should be taken apart for cleaning. Jointed
instruments are to be opened so that water can
flow out of cannulae and blind holes.
Step 2 Set the cycle. Adhere to the guidelines
of the manufacturer of the disinfector.
Step 3 After removing the instruments from
the disinfector, check cannulae, blind holes, etc,
for visible dirt. If required, repeat cycle or clean by
hand.
Cleaning manual
Recommended equipment: commercially available
cleaning agent authorized for medical products
(alkaline – with a pH value < 11); soft brushes
made of nylon; running water
Step 1 Each instrument that can be dismantled
should be taken apart for cleaning. Rinse off
surface dirt from instrument.
Step 2 Apply cleaning agent solution to all surfaces
using a brush. Make sure that jointed instruments
are cleaned in both open and closed positions.
N.B.: A suitable brush must be used for cleaning
cannulae and blind holes so that every part can be
reached. The concentration and residence time as
stated by the cleaning agent manufacturer must be
adhered to unconditionally.
Step 3 Rinse the medical product for a minimum
of 1 minute with clean water. Openings and other
areas which are not easily accessible should be
thoroughly rinsed.
Sterilization Guidelines
Disinfection
Equipment: Commercially available disinfectants
authorized for use with medical products e.g..
MEDICLEAN FORTE) can be used (but only
according to the instructions of the disinfectant
producer).
In the case of automatic cleaning, a final rinse
cycle at 90 °C for 5 minutes can be finally carried
out to provide thermal disinfection.
Drying
Drying as part of the cleaning/ disinfection cycle
should not exceed 110 °C.
Checking, Maintenance and Inspection
• Each instrument or implant is to be inspected
carefully to make sure that all visible dirt has
been removed. If any ingrained dirt is found, the
cleaning/ disinfection cycled should be repeated.
• Any instruments with an attached movable
mechanism should be treated with a commercially
available lubricant authorized for sterilisable
surgical instruments.
• The mobility of movable parts should be checked
to ensure that the planned sequence of motion can
be completely carried out.
• In the case of instruments which can be
reassembled into larger units, check whether the
single parts can be put together easily.
Package
The delivery package is purely for transport use
and not suitable for sterilization.
Sterilization
• The hospital is responsible for in-house
procedures regarding assembly, inspection and
packaging of instruments. Furthermore, the
hospital should recommend protective measures
covering sharp or potentially dangerous parts of
the instruments.
• All instruments and implants should be laid out
in such a way that the steam should reach all the
surfaces.
• Each instrument that can be dismantled should
be taken apart for sterilization.
• Sterilization by means of heat/ steam is the
preferred method for instruments and implants of
I.T.S. GmbH.
• Manufacturer’s recommendations regarding
sterilization appliances should always be followed.
When several instruments are sterilised in one
sterilization cycle, care must be taken not to exceed
the maximum amount of items to be sterilised in
the appliance as stated in the manufacturer’s
instructions.
Cycle
Duration of
sterilization
Temperature
Pressure
Duration of
drying
Prevacuum
5 minutes
134°C
273°F
3,04 bar
27 psi
30 minutes
Prevacuum²
18 minutes
134°C
273 °F
3 bar
28,5 psi
30 minutes
² From the World Health Organization’s (WHO)
recommended disinfection/ steam sterilization
parameters for the reconditioning of instruments
when there is a risk of TSE/CJD contamination
Important Note
• The above-mentioned instructions have been
validated by the manufacturer of medical products
for the preparation of a medical product whose reuse is deemed SUITABLE. It is the responsibility
of the reconditioner to ensure that reconditioning
actually carried out using the equipment, materials
and staff in the preparation facility achieves the
desired results. For this, validation and routine
inspections of the preparation process are
usually necessary. Likewise, any deviation from
the provided instructions by the preparer should
be evaluated for its efficiency and possible
disadvantageous consequences.
• In the case of questions or problems, please
contact us at the address above.
Symbols
Single use
Expiry date (year/month)
Disposal
The valid guidelines of the hospital operator apply
for disposal.
Charge number
Sterilization by steam
Sterilization by radiation
Sterilization by ethylene oxid
Patient Information
Order number
Implantation has consequences for the discomfort,
mobility and general life circumstances of the
patient. For this reason, the patient should be
given instructions for appropriate behaviour after
implantation, and it should be explained to him or
her the necessity of reporting negative changes in
the area of the implant as well as any falls and
accidents which may appear not to have damaged
the implant nor the site of the operation.
Package content (no. of items)
Material used
Size
Pay attention to instructions
RL 93/42/EWG
ÖNORM EN ISO 13485
ISO 17664
Responsibility of the Hospital for Instruments lent
by I.T.S. GmbH
• Surgical instruments generally have a long
service life. But their life expectancy can be quickly
reduced due to misuse or insufficient protection.
Instruments which no longer work correctly,
whether due to wear, misuse or improper care,
have to be disposed of.
• Medical products which are returned to I.T.S.
GmbH must undergo cleaning, disinfection,
inspection and a final sterilization. Products
returned to I.T.S. GmbH must be accompanied by
a confirmation of the decontamination they were
subjected to.
i.t.s.
15
I.T.S. GmbH
part of the MED-HOLD GROUP
Autal 28, 8301 Lassnitzhöhe
Austria
Order No. PL-OP-0111-E
Edition: January/2011
Tel.:+43 | 316 | 211 21 0
Fax:+43 | 316 | 211 21 20
[email protected]
www.its-implant.com
© I.T.S. GmbH Graz/Austria
2011. Subject to technical
alterations, errors and
misprints excepted.