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

® ®
Aesculap Targon
Targon® FN
Applicable to
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For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet
at www.extranet.bbraun.com
Intended use
The Targon® FN system is used for splinting, stabilization and fixation of the proximal femur.
System configurations:
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Targon® FN femoral plate
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Targon® FN Telescrew support screw system in various lengths
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
The operating surgeon is responsible for establishing the above indications and indications beyond those, taking into
account the specific clinical, biological, and biomechanical situation.
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
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Anticipated overloading of the implant
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Inadequate patient compliance
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Foreign body sensitivity to the implant materials
Side effects and interactions
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Changes in position, loosening, wear and tear or fracture of implant components
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Position change and loosening of fragments
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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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Venous thrombosis, lung embolism, cardiac arrest
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Tissue reaction to implant materials
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Trauma to nerves, tendons, or vessels
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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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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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The operating surgeon must be fully conversant with bone anatomy, including the pathways of nerves, blood ves-
sels, muscles, and tendons.
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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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Targon® implants may only be implanted using the Aesculap implantation instruments specially designed for this
purpose.
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Aesculap is not responsible for any complications arising from wrong indication, wrong choice of implant, incor-
rect combination of implant components and operating technique, the limitations of the treatment method, or
inadequate asepsis.
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The instructions for use for individual Aesculap implant components must be followed.
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Follow the operating manual.
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Use implant components only in the appropriate plate drill holes.
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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 that have been used before must not be reused.
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Mobilization, dynamic locking or use of compression involve the risk of migration of the nail and/or the locking
component into the joint region or out of the bone. Therefore 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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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 formation.
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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. One way to achieve this is through mobilization.
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Always insert the Targon® implants in such a way that forces to be transmitted are slight and can be transmitted
by the bone at an early stage.
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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, instruments, and fragments and analyze the origin of the problem. If necessary,
repeat previous operating steps and check the instruments (e.g. for blocked drill helix).
Interactions between MRI and implant components!
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MRI examinations using magnetic fields of 1.5 and 3.0 tesla do not present an
additional risk to implant bearers.
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MRI causes non-critical, localized heat development.
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Implants produce moderate MRI artifacts.
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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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Postoperatively, individual patient information, as well as mobility and muscle training, is of particular impor-
tance.
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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.
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Use the implant system storage devices for processing, sterilization and sterile setup.
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Ensure that the implant components in their implant system storage devices do not come into contact with each
other or with instruments.
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Ensure that the implant components are not damaged in any way.
Prior to resterilization, the implant components must be cleaned using the following validated reprocessing proce-
dure:
Note
Adhere to national statutory regulations, national and international standards and directives, and local, clinical
hygiene instructions for sterile processing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant
national regulations concerning the reprocessing of products.
Note
Successful processing of this medical device can only be ensured if the processing method is first validated. The oper-
ator/sterile processing technician is responsible for this.
The recommended chemistry was used for validation.
Note
If there is no final sterilization, then a virucidal disinfectant must be used.
Note
For the latest information on reprocessing and material compatibility see also the Aesculap extranet at
www.extranet.bbraun.com
The validated steam sterilization procedure was carried out in the Aesculap sterile container system.
Validated reprocessing procedure
Mechanical alkaline cleaning and thermal disinfection
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Place the implants on a tray that is suitable for cleaning (avoiding rinsing blind spots).
Machine type: single-chamber cleaning/disinfection device without ultrasound
Phase Step T
[°C/°F]
I Prerinse <25/77
II Cleaning 55/131
III Intermediate rinse >10/50
IV Thermal disinfection 90/194
V Drying -
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality
at least)
*Recommended: BBraun Helimatic Cleaner alkaline
For implant components that are to be resterilized:
Intraoperative contamination with blood, secretions, and other fluids may render
the affected component unsuitable for resterilization!
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Handle the implants with new gloves only.
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Keep the implant system storage devices covered or closed.
WARNING
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Process implant system storage devices separately from instrument trays.
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Clean implants must not be processed together with contaminated implants.
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Process the implant components individually and separately if no implant sys-
tem storage devices are available, ensuring that the implant components are
not damaged in the process.
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Mechanically clean and disinfect the implant components.
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Do not reuse surgically contaminated implants!
Direct or indirect contamination may render implants unsuitable for resteriliza-
tion!
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Do not reprocess implants that have been directly or indirectly contaminated
with blood.
WARNING
t Water Chemical/Note
quality
[min]
3 D–W -
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10 FD-W
Concentrate, alkaline:
– pH = 13
– < 5 % anionic surfactant
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0.5 % working solution
– pH = 11*
1 FD-W -
5 FD-W -
- - According to the program for cleaning
and disinfection device