B.Braun Aesculap Targon FN Mode D'emploi/Description Technique page 2

®
Aesculap Targon
Targon® FN
Intended use
The Targon® FN system is used for stabilization and fixation of the proximal femur.
Materials
The materials used in the implant are listed on the packaging:
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ISOTAN® titanium forged alloy Ti6Al4V acc. to ISO5832-3
F
The titanium implants are anodized with a colored oxide layer. Slight changes in coloration may occur, but do not
affect the implant quality.
ISOTAN® is a registered trademark of Aesculap AG, 78532 Tuttlingen / Germany.
Indications
Use for:
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Medial femoral neck fractures
Absolute contraindications
Do not use in the presence of:
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Trochanteric femur fractures
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Acute or chronic infections
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Severely damaged bone structures that could prevent stable implantation of implant components
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Bone tumors in the region of implant fixation
Relative contraindications
The following conditions, individual or combined, can lead to delayed healing or compromise the success of the oper-
ation:
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Anticipated overload on the implant
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Medicinal or other drug abuse, or alcoholism
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Expected lack of patient cooperation
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Foreign body sensitivity to the implant materials
Use of the products requires individual, critical assessment by the surgeon.
Side effects and interactions
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Changes in position, loosening, wear and tear on, or fracture of implant components
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Position change and loosening of bone fragments
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Periimplant fractures
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Delayed healing, or non-union and development of pseudarthrosis
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Primary and secondary infections
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Thromboses, embolisms
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Tissue reaction to implant materials
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Injury to the surrounding tissue, including nerve and vascular damage
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Hematomas and wound healing disorders
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Reduced joint mobility and flexibility
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Arthralgia and reduced tolerance for exercise
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Compartment syndrome
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Pain in the implant entry region and in the region of locking components
Safety notes
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It is the operating surgeon's responsibility to ensure that the surgical procedure is performed properly.
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General risk factors associated with surgical procedures are not described in in the present instructions for use.
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The operating surgeon must have a thorough command of both the hands-on and conceptual aspects of the
established operating techniques.
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Use implant components only in the plate holes intended for this purpose.
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Prior to the operation, the operating surgeon must familiarize himself/herself with the Targon® implants and the
associated operating technique.
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It is the operating surgeon's responsibility to ensure the correct combination of implant components and their
implantation.
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The Targon® implants may only be implanted with the Aesculap implantation instruments intended for this pur-
pose.
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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 lack of asepsis.
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The instructions for use for individual Aesculap implant components must be followed.
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The implant components were tested and approved in combination with Aesculap components. If other combi-
nations are used, the responsibility for such action lies with the operating surgeon.
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Do not, under any circumstances, combine implant components from different manufacturers.
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Do not, under any circumstances, use damaged or surgically removed components.
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Implants which have already been used must not be used again.
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The migration paths of the implants and those of the fragments must be considered in the implantation and
taken into account when selecting the implant length.
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The functional lifespan of the system is limited to the duration until bone consolidation. Bone consolidation nor-
mally occurs within three months.
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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 pseudarthrosis develops, or if the implant is overloaded for an exces-
sively long period.
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There are currently no findings regarding the behavior of the implant after bone consolidation. Experiences with
the implant show no uncharacteristic accumulation of complications for this case. After consolidation has
occurred, leaving the implant in the body is associated with risks that the user must weigh against the risks of
removal by operation. The indication for implant removal is relative, and rarely mandatory. It is always made on
an individual basis. There is no evidence-based recommendation. Otherwise, refer to the corresponding applica-
ble guidelines of the Deutsche Gesellschaft für Unfallchirurgie e.V. (DGU).
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Always insert the Targon® implants in such a way that forces to be transmitted are low and can be absorbed from
the bone at an early stage.
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During the postoperative phase, in addition to mobility and muscle training, it is of particular importance that
the surgeon keeps the patient well informed.
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Always use cutting instruments, e.g., drill bits, guide pins, that are sharp.
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Do not apply strong force when implanting or explanting the implants. Should a problem arise, check the position
and orientation of the implants, bone fragments and instruments and analyze the origin of the problem. If nec-
essary, repeat previous operating steps and check the instruments (e.g. for a locking drill)
The implant was not examined for safety and compatibility in MR environments.
It has not been tested for heat, movements or image artifacts during MR exami-
nations. MR-scanning of a patient with this implant can lead to injuries to the
patient.
WARNING
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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.
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Increase the load on the fracture and implant in accordance with the progress of healing.
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In order to promote the earliest possible detection of any problems or complications, the operation results must
be followed up at regular intervals with the aid of appropriate examination procedures. A precise diagnosis
requires x-rays taken in the directions anterior-posterior and medial-lateral.
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At the time of follow-up exams, the scope of postoperative load and 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 inju-
ries. Also, the dimensions of the implant should be taken into account.
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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
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The implant components come individually packed in protective packaging that is labeled according to its con-
tents.
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The implant components are gamma-sterilized.
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Store implant components in their original packaging. Remove them from their original protective packaging
only just prior to application.
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Prior to use, check the product expiry date and verify the integrity of the sterile packaging.
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Do not use implant components that are past their expiration date or whose packaging is damaged.
Damage to implants caused by processing and resterilization!
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Do not reprocess or resterilize the implants.
WARNING
Application
The operating surgeon shall devise an operation plan that specifies and accurately documents the following:
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Selection of the implant components and their dimensions
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Positioning of the implant components in/on the bone
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Intraoperative orientation points
The following conditions must be fulfilled prior to application:
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All requisite implant components are ready to hand.
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All requisite implantation instruments must be available and in working order, including specialized Aesculap
implantation systems.
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The operating surgeon and operating room team are thoroughly familiar 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.
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The operating surgeon is fully conversant with the rules governing medical practice, the current state of scientific
knowledge, and the contents of relevant scientific articles by medical authors.
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The manufacturer has been consulted if the preoperative situation was unclear and if implants were found in the
area operated on.
The surgical procedure and following information has been explained to the patient, and the patient's consent has
been documented:
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Treatment of a fracture with implants may not always be successful in completely restoring the original bone
anatomy.
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Following the fracture treatment, the functionality of adjacent joints may be restricted.
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Pains may occur following the fracture treatment.
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The implants must not be exposed to overload due to excessive strains, hard physical work or sports activities.
Overstraining entails the risk of implant loosening or breakage.
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The patient must be informed of the limited load capacity of the implant and must be given appropriate behavior
guidelines. The implants will not sustain the load and functionality of a healthy bone. The risks of transgressing
these rules must be explained to the patient.
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If the implant loosens, fragments migrate, or pseudoarthrosis develops, a revision operation may be required.
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The patient must undergo regular medical follow-up examinations.
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Check for correct mounting of the plate on 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 incorrect assessment/treatment of the
fracture!
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Use support screws of the appropriate length.
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Make certain that implants are aligned correctly.
WARNING
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Handle the implants with appropriate care.
Implant removal
The attending physician decides when to remove, in part or completely, the osteosynthesis implants through another
surgical procedure.
Note
Implant removal can give rise to complications due to implants that are locked in place, ingrown bone tissue, etc. Such
complications can lead to damage to implants and/or instruments. For such cases a set of special instruments is rec-
ommended, which can be ordered from Aesculap. This instrument set should be at hand for every explantation. Other
special instruments are available for dealing with broken implants. Note the instructions for use for such cases!
Further information on Aesculap implant systems is available from B. Braun/Aesculap or the appropriate
B. Braun/Aesculap office.
Disposal
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Adhere to national regulations when disposing of or recycling the product, its components and its packaging.
TA-Nr. 012010 2018-12 V6 Änd.-Nr. 59153