B.Braun Aesculap Orthopaedics Targon FN Mode D'emploi page 2

Targon® FN
Intended use
The Targon® FN system is used for splinting, stabilization and fixation of the
proximal femur.
System variants:
• Targon® FN femoral plate
• Targon® FN Telescrew support screw system in various lengths
Materials
The materials used in the implant are listed on the package.
• ISOTAN® titanium forged alloy Ti6Al4V to ISO 5832-3
F
The titanium implants are coated with a colored oxide. Their color may
change slightly, but this has no bearing on the quality of the implant.
ISOTAN® is a registered trademark of Aesculap AG, 78532 Tuttlingen /
Germany.
Indications
Use for:
• Medial femoral neck fractures
The operating surgeon is responsible for establishing the above indications
and indications beyond those, taking into account the specific clinical, bio-
logical and biomechanical situation.
Contraindications
Do not use in the presence of:
• Trochanteric femur fractures
• Acute or chronic infections
• Severely damaged bone structures that could prevent stable implantation
of implant components
• Bone tumors in the region of implant fixation
• Anticipated overloading of the implant
• Inadequate patient compliance
• Foreign body sensitivity to the implant materials
Side-effects and adverse interactions
• Changes in position, loosening, wear and tear or fracture of implant com-
ponents
• Position change and loosening of fragments
• Delayed healing, or non-union and development of pseudoarthrosis
• Primary and secondary infections
• Venous thrombosis, lung embolism, and cardiac arrest
• Tissue reaction to implant materials
• Trauma to nerves, tendons or vessels
• Hematomas and wound healing disorders
• Reduced joint mobility and flexibility
• Arthralgia and reduced tolerance for exercise
• Pain in the implant entry region and in the region of locking components
Safety notes
• The implant components were tested and approved for use in combina-
tion with Aesculap components. If other combinations are used, the
responsibility for such action lies with the operating surgeon.
• It is the operating surgeon's responsibility to ensure that the surgical pro-
cedure is performed properly.
• The operating surgeon must have a thorough command of both the
hands-on and conceptual aspects of the established operating tech-
niques.
• Always observe the instructions for use of the individual Aesculap implant
components.
• Follow the OP manual.
• Use implant components only in the appropriate plate drill holes.
• The operating surgeon must be thoroughly familiar with the bone anat-
omy, including the pathways of nerves, blood vessels, muscles and ten-
dons.
• Prior to the operation, the operating surgeon must familiarize him/herself
with the Targon® implants and associated operating technique.
• It is the operating surgeon's responsibility to ensure the correct combina-
tion of implant components and their implantation.
• The Targon® implants may only be implanted with the Aesculap implan-
tation instruments designed for this purpose.
• Aesculap is not responsible for any complications arising from incorrect
diagnosis, choice of incorrect implant, incorrectly combined implant
components and/or operating techniques, the limitations of treatment
methods, or inadequate asepsis.
• Under no circumstances may implant components from different suppli-
ers be combined.
• Implants that have already been used must not be reused.
• The implant components applied, along with their article numbers, the
name of the implant, as well as the batch number and serial number (if
available) must be documented in all patient records.
• Considerably higher strain due to increased leverage is to be expected if
there are locking holes at the height or in the region of the fracture line.
This can lead to implant failure. Accordingly, postoperative strain has to
be reduced, or full load may be envisaged only after complete callus for-
mation.
• Overloading the implant can cause the implant material to fracture. The
dynamic load on the implant must be reduced if healing fails to occur or
is slow, if pseudoarthrosis develops, or if the implant is overloaded for an
excessively long period. This can be achieved e.g. through dynamizing.
• Always insert the Targon® implants in such a way that forces to be trans-
mitted are slight and can be transmitted by the bone at an early stage.
• During the postoperative phase, in addition to mobility and muscle train-
ing, it is of particular importance that the physician keeps the patient well
informed.
• In order to promote the earliest possible detection of any problems or
complications, the operation results must be followed up at regular inter-
vals with the aid of appropriate examination procedures. A precise diag-
nosis requires x-rays taken in the directions anterior-posterior and
medial-lateral.
• Never use damaged implant components or implant components that
have been removed surgically.
• Do not apply strong force when implanting or explanting the implants.
Should a problem arise, check the position and orientation of the
implants, instruments and fragments and analyze the origin of the prob-
lem. If necessary, repeat previous operating steps and check the instru-
ments (e.g. for blocked drill helix).
• Increase the load on the fracture and implant in accordance with the
progress of healing.
• The timing of follow-up examinations, the type of postoperative load and
the aftercare should be determined for each patient on the basis of their
weight, their activities, the type and severity of the fracture, and any
coexisting injuries. The dimensions of the implant should also be taken
into account.
• Recommended follow-up intervals:
– prior to the patient's discharge from hospital
– 10-12 weeks post operationem
– 6 months post operationem
– 12 months post operationem
Sterility
• The implant components come individually packed in protective packag-
ing that is labeled according to its contents.
• The implant components have been sterilized by irradiation (min. dose
25 kGy).
Store implant components in their original packaging. Remove them from
their original protective packaging only just prior to application.
Prior to use, check the product expiry date and verify the integrity of the
sterile packaging. Do not use implant components that are past their
expiry date or whose packaging is damaged.
Resterilization
Risk of contamination of the patient!
Never resterilize or reuse implants contami-
nated e.g. with blood or secretions.
WARNING
Targon® FN implants to which the above restrictions do not apply can be
resterilized through steam sterilization preceded by appropriate pre-
cleaning, ultrasound treatment and disinfection.
Make sure the implant mechanism is not damaged during cleaning and
resterilization.
The responsibility for resterilization of implant components lies with the end
user. In certain countries (e.g. France) such resterilization is specifically pro-
hibited.
Sterilization method and parameters
Observe all relevant national regulations and standards with regard to
processing.
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or pos-
sible variants of CJD, observe the relevant national regulations concern-
ing the reprocessing of the products.
Up-to-date information on processing can be found on the Aesculap
Extranet at www.aesculap-extra.net
Sterilize with steam, taking note of the following:
Carry out steam sterilization through an approved steam sterilization
procedure (e.g. sterilizer in conformance with EN 285/ANSI/AAMI/
ISO 11134-1993, ANSI/AAMI ST46-1993 and validated in conformance
with EN 554/ISO 13683). For the fractionated vacuum process, steriliza-
tion has to be carried out running the 134 °C/2 bar program for a mini-
mum holding time of 5 minutes.
Application
The operating surgeon shall devise an operation plan that specifies and accu-
rately documents the following:
• Selection of the implant components and their dimensions
• Positioning of the implant components in the bone
• Location of intraoperative landmarks
The following conditions must be fulfilled prior to application:
• All requisite implant components are ready to hand.
• Operating conditions are highly aseptic.
• Implantation instruments, including the special Aesculap implant system
instruments, must be complete and in working condition.
• The operating surgeon and operating room team are thoroughly conver-
sant with the operating technique and with the available range of
implants and instruments; information materials on these subjects must
be complete and ready to hand.
• The operating surgeon is familiar with the rules governing medical prac-
tice, the current state of scientific knowledge, and the contents of rele-
vant articles by medical specialists from professional literature.
• The manufacturer has been consulted if the preoperative situation was
unclear and if implants were found in the area operated on.
The surgical intervention has been explained to the patient and their agree-
ment concerning the following information has been recorded:
• Treatment of a fracture with implants may not always be successful in
completely restoring the original bone anatomy.
• Following the fracture treatment, the functionality of adjacent joints may
be restricted.
• Following treatment of a fracture, pain may develop.
• The implants must not be subjected to overload through excessive strains,
hard physical work or sports activities. The implant may loosen or suffer
material fracture due to excessive strain e.g. suffered in a fall.
• The patient must be informed of the limits to the allowable strain on the
implant, and be given appropriate behavior guidelines. The implants will
not sustain the load and functionality of a healthy bone. The risks inher-
ent in transgressing the behavior guidelines must be made clear to the
patient.
• Corrective surgery may become necessary in cases of implant loosening,
fragment migration, pseudarthroses or other complications.
• The patient must undergo a regular medical follow-up examination.
• The attending physician decides the appropriate timing of the surgical
removal, in part or completely, of the osteosynthesis implants.
Check for correct mounting of the plate at the aiming device: Insert the
drill through the drill sleeve and the aiming hole and guide it through
the plate hole.
Complications due to incorrect use and/or incor-
rect assessment/treatment of the fracture!
Use support screws of the appropriate length.
Ensure that implants are aligned correctly.
WARNING
Handle the implants with appropriate care.
Explantation
Note
Implant removal can give rise to complications due to implants that are stuck,
ingrown bone tissue, etc. Such complications can lead to damage to implants
and/or instruments. For such cases a set of special instruments is recom-
mended, which can be ordered from Aesculap. This instrument set should be at
hand for every explantation. Other special instruments are available for deal-
ing with broken implants. Note the instructions for use for such case!
Further information on B. Braun/Aesculap implant systems can be obtained
from B. Braun/Aesculap or the relevant B. Braun/Aesculap agency.
TA-Nr.: 012010 01/11 Änd.-Nr.: 41642