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Instructions for Use Femoral Recon Nail Advanced System

This instruction for use is not intended for distribution in the USA.

Not all products are currently available in all markets. 04/2021 SE_793147 AC All rights reserved.

 © Synthes GmbH 2021. Instructions for Use

Femoral Recon Nail, Femoral Recon Nail, Greater Trochanter B 9 mm Greater Trochanter B 14 mm Right Left Length Right Left Length 04.033.958S 04.033.959S 280 04.033.460S 04.033.461S 300 04.033.960S 04.033.961S 300 04.033.462S 04.033.463S 320 04.033.962S 04.033.963S 320 04.033.464S 04.033.465S 340 04.033.964S 04.033.965S 340 04.033.466S 04.033.467S 360 04.033.966S 04.033.967S 360 04.033.468S 04.033.469S 380 04.033.968S 04.033.969S 380 04.033.470S 04.033.471S 400 04.033. 04.033.971S 400 04.033.472S 04.033.473S 420 04.033.972S 04.033.973S 420 04.033.474S 04.033.475S 440 04.033.974S 04.033.975S 440 04.033.476S 04.033.477S 460 04.033.976S 04.033.977S 460 04.033.478S 04.033.479S 480 04.033.978S 04.033.979S 480 Femoral Recon Nail, Femoral Recon Nail, Piriformis Fossa B 9 mm Greater Trochanter B 10 mm Right Left Length Right Left Length 04.033.928S 04.033.929S 280 04.033.058S 04.033.059S 280 04.033.930S 04.033.931S 300 04.033.060S 04.033.061S 300 04.033.932S 04.033.933S 320 04.033.062S 04.033.063S 320 04.033.934S 04.033.935S 340 04.033.064S 04.033.065S 340 04.033.936S 04.033.937S 360 04.033.066S 04.033.067S 360 04.033.938S 04.033.939S 380 04.033.068S 04.033.069S 380 04.033. 04.033.941S 400 04.033.070S 04.033.071S 400 04.033.942S 04.033.943S 420 04.033.072S 04.033.073S 420 04.033.944S 04.033.945S 440 04.033.074S 04.033.075S 440 04.033.946S 04.033.947S 460 04.033.076S 04.033.077S 460 04.033.948S 04.033.949S 480 04.033.078S 04.033.079S 480 Femoral Recon Nail, Femoral Recon Nail, Piriformis Fossa B 10 mm Greater Trochanter B 11 mm Right Left Length Right Left Length 04.033.028S 04.033.029S 280 04.033.160S 04.033.161S 300 04.033.030S 04.033.031S 300 04.033.162S 04.033.163S 320 04.033.032S 04.033.033S 320 04.033.164S 04.033.165S 340 04.033.034S 04.033.035S 340 04.033.166S 04.033.167S 360 04.033.036S 04.033.037S 360 04.033.168S 04.033.169S 380 04.033.038S 04.033.039S 380 04.033.170S 04.033.171S 400 04.033.040S 04.033.041S 400 04.033.172S 04.033.173S 420 04.033.042S 04.033.043S 420 04.033.174S 04.033.175S 440 04.033.044S 04.033.045S 440 04.033.176S 04.033.177S 460 04.033.046S 04.033.047S 460 04.033.178S 04.033.179S 480 04.033.048S 04.033.049S 480

Femoral Recon Nail, Femoral Recon Nail, Greater Trochanter B 12 mm Piriformis Fossa B 11 mm Right Left Length Right Left Length 04.033.260S 04.033.261S 300 04.033.130S 04.033.131S 300 04.033.262S 04.033.263S 320 04.033.132S 04.033.133S 320 04.033.264S 04.033.265S 340 04.033.134S 04.033.135S 340 04.033.266S 04.033.267S 360 04.033.136S 04.033.137S 360 04.033.268S 04.033.269S 380 04.033.138S 04.033.139S 380 04.033.270S 04.033.271S 400 04.033.140S 04.033.141S 400 04.033.272S 04.033.273S 420 04.033.142S 04.033.143S 420 04.033.274S 04.033.275S 440 04.033.144S 04.033.145S 440 04.033.276S 04.033.277S 460 04.033.146S 04.033.147S 460 04.033.278S 04.033.279S 480 04.033.148S 04.033.149S 480

SE_793147 AC page 2 / 6 Femoral Recon Nail, Locking Screw for Medullary Nails, Low Profile, B 5 mm* Piriformis Fossa B 12 mm Length (mm) Length (mm) Right Left Length 04.045.326 26 04.045.366 66 04.033.230S 04.033.231S 300 04.045.328 28 04.045.368 68 04.033.232S 04.033.233S 320 04.045.330 30 04.045.370 70 04.033.234S 04.033.235S 340 04.045.332 32 04.045.372 72 04.033.236S 04.033.237S 360 04.045.334 34 04.045.374 74 04.033.238S 04.033.239S 380 04.045.336 36 04.045.376 76 04.033.240S 04.033.241S 400 04.045.338 38 04.045.378 78 04.033.242S 04.033.243S 420 04.045.340 40 04.045.380 80 04.033.244S 04.033.245S 440 04.045.342 42 04.045.382 82 04.033.246S 04.033.247S 460 04.045.344 44 04.045.384 84 04.033.248S 04.033.249S 480 04.045.346 46 04.045.386 86

Femoral Recon Nail, 04.045.348 48 04.045.388 88 Piriformis Fossa B 14 mm 04.045.350 50 04.045.390 90 Right Left Length 04.045.352 52 04.045.395 95 04.033.430S 04.033.431S 300 04.045.354 54 04.045.400 100 04.033.432S 04.033.433S 320 04.045.356 56 04.045.405 105 04.033.434S 04.033.435S 340 04.045.358 58 04.045.410 110 04.033.436S 04.033.437S 360 04.045.360 60 04.045.415 115 04.033.438S 04.033.439S 380 04.045.362 62 04.045.420 120 04.033.440S 04.033.441S 400 04.045.364 64 04.033.442S 04.033.443S 420 FRNA End Caps 04.033.444S 04.033.445S 440 Length (mm) 04.033.446S 04.033.447S 460 04.045.800S 0 04.033.448S 04.033.449S 480 04.045.805S 5 Recon Screw for Medullary Nails, B 6.5 mm 04.045.810S 10 Length (mm) Length (mm) 04.045.815S 15 04.046. 60 04.046. 100 04.045.820S 20 04.046.665S 65 04.046.705S 105 Nut and Washers 04.046. 70 04.046.710S 110 04.045.780S Washer B 14/7 04.046.675S 75 04.046.715S 115 04.045.781S Nut B 14 04.046.680S 80 04.046.720S 120 04.045.782S Washer B 17.5/11.8 04.046.685S 85 04.046.725S 125 Alternatively, the FRNA implants can be applied using associated instrumentation 04.046. 90 04.046.730S 130 and a set of the following compatible screw implants: 04.046.695S 95 6.5 mm Titanium Recon Screws* Stardrive® Locking Screw for Medullary Nails, B 5 mm* Length (mm) Length (mm) Length (mm) Length (mm) 04.003.022 60 04.003.030 100 04.045.026 26 04.045.066 66 04.003.023 65 04.003.031 105 04.045.028 28 04.045.068 68 04.003.024 70 04.003.032 110 04.045.030 30 04.045.070 70 04.003.025 75 04.003.033 115 04.045.032 32 04.045.072 72 04.003.026 80 04.003.034 120 04.045.034 34 04.045.074 74 04.003.027 85 04.003.035 125 04.045.036 36 04.045.076 76 04.003.028 90 04.003.036 130 04.045.038 38 04.045.078 78 04.003.029 95 04.045.040 40 04.045.080 80 04.045.042 42 04.045.082 82 Locking Screw Stardrive® B 5 mm* 04.045.044 44 04.045.084 84 Length (mm) Length (mm) 04.045.046 46 04.045.086 86 Length (mm) 0 04.005.548 58 04.045.048 48 04.045.088 88 04.005.516 26 04.005.550 60 04.045.050 50 04.045.090 90 04.005.518 28 04.005.552 62 04.045.052 52 04.045.095 95 04.005.520 30 04.005.554 64 04.045.054 54 04.045.100 100 04.005.522 32 04.005.556 66 04.045.056 56 04.045.105 105 04.005.524 34 04.005.558 68 04.045.058 58 04.045.110 110 04.005.526 36 04.005.560 70 04.045.060 60 04.045.115 115 04.005.528 38 04.005.562 72 04.045.062 62 04.045.120 120 04.005.530 40 04.005.564 74 04.045.064 64 04.005.532 42 04.005.566 76 04.005.534 44 04.005.568 78 04.005.536 46 04.005.570 80 04.005.538 48 04.005.575 85 04.005.540 50 04.005.580 90 04.005.542 52 04.005.585 95 04.005.544 54 04.005.590 100 04.005.546 56

SE_793147 AC page 3 / 6 Titanium End Caps* Stardrive® Patient Target Group Length (mm) The Femoral Recon Nail Advanced System implants are recommended for use in skeletally mature patients. 04.003.000 0 04.003.001 5 04.003.002 10 Intended User This IFU alone does not provide sufficient background for direct use of the device 04.003.003 15 or system. Instruction by a surgeon experienced in handling these devices is highly 04.003.004 20 recommended.

This device is intended to be used by qualified health care professionals e.g. sur- * Available non-sterile or sterile packed. Add “S” to the catalogue number to order geons, physicians, operating room staff, and individuals involved in preparation of sterile products. the device. All personnel handling the device should be fully aware of the IFU, the surgical procedures, if applicable, and /or the Synthes “Important Information” Products available non-sterile and sterile can be differentiated with the suffix “S” brochure as appropriate. added to the article number for sterile products. Implantation is to take place according to the instructions for use following the The screws are also available in sterile tube packaging (corresponding article num- recommended surgical procedure. The surgeon is responsible for ensuring that the ber with suffix “TS”). device is suitable for the pathology/condition indicated and that the operation is carried out properly. Screw length designations are defined to reflect the readings on the length mea- surement tools and do not necessarily correspond to the actual total length of the screw. Expected Clinical Benefits Expected clinical benefits of internal fixation devices such as FRNA implants when used according to instructions for use and recommended technique are: Introduction –– Stabilize bone segment and facilitate healing The Femoral Recon Nail Advanced (FRNA) System consists of cannulated femoral –– Restore anatomical alignment and extremity function recon nails which accept commercially available Titanium End Caps, 6.5 mm Titani- um Recon Screws and 5.0 mm Titanium Locking Screws. The Femoral Recon Nail is anatomically contoured and tapers to a nominal diameter of 9, 10, 11, 12, or Performance Characteristics of the Device 14 mm. Femoral Recon Nails are available in lengths from 280 mm (only for nominal The FRNA System offers the choice of Piriformis Fossa (PF) or Greater Trochanter diameter 9 and 10 mm) to 480 mm in right and left versions. This system is manu- (GT) entry points and extensive locking options to accommodate varying surgical factured from titanium alloy. preferencing when enabling the treatment of a range of fracture complexity. Fem- oral Recon Nails were designed for anatomical fit with a 1.0 m radius of curvature Important note for medical professionals and operating room staff: These instruc- and short proximal nail end to better fit patient anatomy. tions for use do not include all the information necessary for selection and use of a device. Please read the instructions for use and the Synthes brochure “Important Information” carefully before use. Ensure that you are familiar with the appropriate Potential Adverse Events, Undesirable Side Effects and Residual Risks surgical procedure. –– Adverse tissue reaction, allergy/hypersensitivity reaction –– Bone damage including intra- and post-operative bone fracture, osteolysis, or bone necrosis Materials –– Damage to vital organs or surrounding structures Device(s) Material(s) Standard(s) –– Embolism –– Infection Nails, Recon Screws, Ti-6Al-7Nb ISO 5832-11 –– Injury to user Locking Screws, End (TAN) ASTM F1295 –– Malunion/Non-union Caps, Nut Titanium Alloy –– Neuro-vascular damage Washers TiCP ISO 5832-2 –– Pain or discomfort ASTM F67 –– Poor joint mechanics –– Soft tissue damage (including compartment syndrome) –– Symptoms resulting from Implant migration, loosening, bending, or beakage Intended Use The Recon Femoral Nailing Implants are intended for temporary fixation and stabi- lization of fractures of the femur – neck, shaft and distal femur. Sterile Device

Sterilized using irradiation Indications Standard Locking Indications: Store sterile devices in their original protective packaging, and do not remove them The Femoral Recon Nail with standard locking is indicated for fractures in the fem- from the packaging until immediately before use. oral shaft: 32-A/B/C (except subtrochanteric fractures 32-A [1–3].1, 32-B [1–3].1) and 32-C [1–3].1) Do not use when packaging is damaged.

Recon Locking Indications Prior to use, check the product expiration date and verify the integrity of the sterile The Femoral Recon Nail with recon locking is indicated for fractures in the femoral packaging. Do not use if the package is damaged or date of expiration has passed. shaft in case of combination with femoral neck fractures: 32-A/B/C combined with 31-B (double ipsilateral fractures) Additionally, the Femoral Recon Nail is indicated for fractures in the subtrochanter- Single-use Device ic section: 32-A [1–3].1, 32-B [1–3].1 and 32-C [1–3].1 Do not re-use. Contraindications No contraindication specific to these devices. Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.

Re-use or clinical reprocessing (e.g. cleaning and resterilization) compromise the structural integrity of the device and/or lead to device failure which may result in patient injury, illness or death. Furthermore, reuse or reprocessing of single-use devices may create a risk of con- tamination e.g. due to the transmission of infectious material from one patient to another. This could result in injury or death of the patient or user.

Contaminated implants must not be reprocessed. Any Synthes implant that has been contaminated by blood, tissue, and/or bodily fluids/matter should never be used again and should be handled according to hospital protocol. Even though they may appear undamaged, the implants may have small defects and internal stress patterns that may cause material fatigue.

SE_793147 AC page 4 / 6 Warnings and Precautions Treatment before Device is used The general risks associated with surgery are not described in these instructions for use. For more information, please refer to the Synthes brochure “Important Infor- Non-sterile Device: mation”. Synthes products supplied in a non-sterile condition must be cleaned and steam-sterilized prior to surgical use. Prior to cleaning, remove all original packag- It is strongly advised that FRNA implants are implanted only by operating surgeons ing. Prior to steam-sterilization, place the product in an approved wrap or contain- who are familiar with the general problems of trauma surgery and who are able to er. Follow the cleaning and sterilization instruction given by the Synthes brochure master the product-specific surgical procedures. Implantation is to take place with “Important Information”. the instructions for the recommended surgical procedure. The surgeon is respon- sible for ensuring that the operation is carried out properly. Sterile Device: The devices are provided sterile. Remove products from the package in an aseptic The manufacturer is not responsible for any complications arising from incorrect manner. diagnosis, choice of incorrect implant, incorrectly combined implant components Store sterile devices in their original protective packaging, and do not remove them and/or operating techniques, the limitations of treatment methods, or inadequate from the packaging until immediately before use. asepsis. Prior to use, check the product expiration date and verify the integrity of the sterile packaging. Do not use, if the package is damaged.

WARNINGS –– It is critical to ensure proper selection of the implant meets the needs of the Implant Removal patient anatomy and the presenting trauma. In case the physician decides to remove the implants, the following steps shall be –– Use of these devices is not recommended when there is systemic infection, infec- followed: tion localized to the site of the proposed implantation or when the patient has demonstrated allergy or foreign body sensitivity to any of the implant materials. 1. Carefully dissect the soft tissues and visualize the end cap. Remove the end cap –– Physician should consider patient bone quality to ensure it provides adequate with a retaining Synthes screwdriver. fixation to promote healing. 2. Carefully dissect the soft tissues and visualize the screw heads. In the case of –– Conditions that place excessive stresses on bone and implant such as severe screw head overgrowth or damaged recess, optional instruments are available obesity or degenerative diseases should be considered. The decision whether to for screw removal for example if required, a curette and a sharp hook to clear use these devices in patients with such conditions must be made by the physician recess from tissue; an extractor shaft and a conical extraction screw to remove taking into account the risks versus the benefits to the patients. screws with damaged recess. Remove all locking screws except one. –– Compromised vascularity in the site of proposed implantation may prevent ade- 3. Thread the extraction screw into the nail. quate healing and thus preclude the use of this or any orthopaedic implant. 4. Remove the remaining locking screw. –– Physician should take into account an increase in medullary pressure occurring 5. Remove the nail. during medullary nailing or reaming. This releases varying amounts of bone mar- row and fat into the venous blood system. Troubleshooting Any serious incident that has occurred in relation to the device should be reported PRECAUTIONS to the manufacturer and the competent authority of the Member State in which For additional precautions specific to a surgical step, please refer to the Special the user and/or patient is established. Operating Instructions.

Clinical Processing of the Device Combination of Medical Devices Detailed instructions for processing of implants and reprocessing of reusable de- Synthes has not tested compatibility with devices provided by other manufacturers vices, instrument trays and cases are described in the Synthes brochure “Important and assumes no liability in such instances. Information”.

Magnetic Resonance Environment Device-related Storage and Handling Information

Torque, Displacement and Image Artifacts according to ASTM F 2213-06, Caution, see instructions for use. ASTM F 2052-14 and ASTM F2119-07 Non-clinical testing of worst case scenario in a 3 T MRI system did not reveal any relevant torque or displacement of the construct for an experimentally measured Additional device-specific Information local spatial gradient of the magnetic field of 3.69 T/m. The largest image artifact extended approximately 169 mm from the construct when scanned using the Gra- Reference number dient Echo (GE). Testing was conducted on a 3 T MRI system.

Radio-Frequency-(RF-)induced heating according to ASTM F2182-11a Lot or batch number Non-clinical electromagnetic and thermal testing of worst case scenario lead to peak temperature rise of 9.5 °C with an average temperature rise of 6.6 °C (1.5 T) and a peak temperature rise of 5.9 °C (3 T) under MRI Conditions using RF Coils Legal manufacturer (whole body averaged specific absorption rate [SAR] of 2 W/kg for 6 minutes [1.5 T] and for 15 minutes [3 T]). Expiration date Precautions: The above mentioned test relies on non-clinical testing. The actual temperature rise in the patient will depend on a variety of factors beyond the SAR and time of RF application. Thus, it is recommended to pay particular attention to the following Disposal points: Any Synthes implant that has been contaminated by blood, tissue, and/or bodily –– It is recommended to thoroughly monitor patients undergoing MR scanning for fluids/matter should never be used again and should be handled according to perceived temperature and/or pain sensations. hospital protocol. –– Patients with impaired thermoregulation or temperature sensation should be excluded from MR scanning procedures. Devices must be disposed of as a healthcare medical device in accordance with –– Generally, it is recommended to use a MR system with low field strength in the hospital procedures. presence of conductive implants. The employed specific absorption rate (SAR) should be reduced as far as possible. –– Using the ventilation system may further contribute to reduce temperature in- crease in the body.

SE_793147 AC page 5 / 6 Special Operating Instructions 12. Proximal locking. If the use of recon screws is planned, it is recommended to perform proximal lock- 1. Position the patient in the lateral decubitus or supine position on a fracture ing prior to distal locking. table or radiolucent operating table. Position the image intensifier to allow visual- Precaution: Proximal locking with the antegrade locking option is not permitted ization of the proximal femur in both the AP and lateral planes. when using recon screws. Precaution: If the use of recon screws is intended in combination with one trans- 2. Reduce fracture. verse locking screw, the locking screw must be inserted in the static position of the locking slot (distal position of the transverse locking slot). This prevents the trans- 3. Determine nail length and diameter. verse locking screw from interfering with the recon screw. Consult the recon lock- Measure using the radiographic ruler. ing section for detailed steps. Alternative: Nail length may also be determined by using a reaming rod. Standard locking. 4. Identify nail entry point. Do not exert forces on the aiming arm, protection sleeves and drill sleeves. These Make a longitudinal incision proximal to the tip of the greater trochanter. forces may prevent accurate targeting through the proximal locking holes and Greater trochanter: In the AP view, the nail insertion point is on the tip or slightly damage the drill bits. lateral to the tip of the greater trochanter, in the curved extension of the medullary Read length from the calibrated drill bits or measure length using depth gauge for cavity. This represents a point, 5° lateral of the femoral shaft axis, measured from locking screws. a point just below the lesser trochanter, as the ML angle of the nail is 5°. Precaution: Select adequate screw length to avoid protrusion of the screw tip and Piriformis fossa: The entry point for the piriformis fossa nail is in line with the med- irritation of soft tissue. ullary canal in the AP and lateral views. The point is posterior in the proximal femur, 5.0 mm locking screws can be connected to the screwdriver with the associated in the piriformis fossa, but varies with patient anatomy. retention pin; this does not apply to the alternative locking screws Stardrive®. Precaution: The screw must not be tightened with the power tool. Disengage the 5. Insert guide wire. power tool from the screwdriver shaft before the screw is fully seated and use the Confirm guide wire placement in both the AP and lateral planes. Insert to a depth manual handle to bring the screw to its final position. of approximately 15 cm. Recon locking. 6. Open medullary canal. Do not exert forces on the aiming arm, protection sleeves and wire guide. These Using the protection sleeve and cannulated drill bit, drill over the 3.2 mm guide forces may prevent accurate targeting through the locking holes. wire or reaming rod until the drill stop on the drill reaches the protection sleeve. It is recommended to place the inferior guide wire first and then the superior guide For the larger, 14 mm nails, in addition to the 14 mm drill bit, the use of the med- wire. ullary reaming system is needed to open the femur. In this case, use the 14 mm drill Read the length of the required recon screw directly on the measuring device. bit for initial opening and continue using the medullary reaming system. Attach the drill stop to the stepped drill bit for the appropriate screw length. Drill to the stop. Monitor the position of the stepped drill bit under image intensification. 7. Ream medullary canal for 14 mm diameter nails. Optional for 9–12 mm Insert the appropriate recon screw through the protection sleeve into the femoral nails. head. Option: The reaming protection system is used to help protect the proximal me- Precaution: Prior to screw insertion in dense bone, consider using the recon screw taphysis during reaming avoiding undesired enlargement of the entry point or tap. Screws can be partially inserted under power using the screwdriver with quick reaming of the lateral wall. coupling, followed by final tightening with the manual screwdriver. The insertion of the transverse locking screw is not permitted if the protection sleeve interferes 8. Assemble insertion instruments. with the head of the inferior recon screw. Match the geometry of the handle to the nail by aligning the arrow on the nail with Precaution: The insertion of the locking screw in the dynamic position of the lock- the line on the barrel of the insertion handle and connect the nail to the insertion ing slot (DYNAMIC/ DYNA for dynamic locking in the aiming arm) is NOT permitted. handle. Pass the connecting screw through the insertion handle and securely tight- en with the ball hexagonal screwdriver. 13. Distal locking. Precaution: Ensure that the connection between the nail and the insertion handle Precaution: Stop drilling immediately after penetrating both cortices. is tight. Retighten if necessary. Read length from the calibrated drill bits or measure length using depth gauge for Precaution: Do not attach the aiming arm to the handle yet. locking screws. Precaution: Reconfirm that the correct nail (e.g. type of entry point nail, right or Precaution: Select adequate screw length to avoid protrusion of the screw tip and left sides) is assembled. irritation of soft tissue. Precaution: The screw must not be tightened with the power tool. Disengage the 9. Insert nail. power tool from the screwdriver shaft before the screw is fully seated and use the Greater trochanter entry point nails: Orient the insertion handle anteriorly un- manual handle to bring the screw to its final position. til the nail reaches the isthmus. As the nail is advanced, rotate the handle so it is Ensure drill bits, screws, nuts or washers do not interfere with other medical devic- positioned laterally for final seating. es (e.g. knee prosthesis, nail, other screws) and/or critical anatomy (e.g. condylar Piriformis fossa entry point nails: Orient the insertion handle laterally during notch, joint space). insertion. Nut should only be used with the 5.0 mm Locking Screws for Medullary Nails. When using a reaming rod, pass the cannulated nail over the reaming rod and into the femoral opening. 14. Insert endcap. Under image intensification, verify fracture reduction and nail insertion in AP and 0 mm end cap: Remove the connecting screw using the ball hexagonal screw- lateral views. driver while leaving the insertion handle connected to the nail. Insert the 0 mm end Note: If nail insertion is difficult, use the C-arm to confirm that there is no obstruc- cap through the insertion handle. tion of the intramedullary canal. If no obstruction was found, choose a smaller 5–20 mm end cap: Remove the connecting screw using the ball hexagonal screw- diameter nail or ream the intra- medullary canal to a larger diameter. driver, remove the insertion handle from the nail. Optional: To use a hammer, screw the driving cap into the insertion handle and Thread the end cap into the nail until it is fully inserted. tighten with the ratchet wrench. Precaution: Confirm that the nail is tightly connected to the insertion handle as hammering may loosen the connection. Retighten if necessary. Precaution: Do not strike the insertion handle directly.

10. Check proximal nail position. Synthes GmbH Check final nail position under image intensification in AP and lateral views. Eimattstrasse 3 If the use of recon screws is planned, nail insertion must be performed based on 4436 Oberdorf the estimated position of the recon screws in the femoral neck. Switzerland Tel: +41 61 965 61 11 11. Check distal nail position. www.jnjmedicaldevices.com Use image intensification to ensure the nail is centered in both AP and lateral views. Verify fracture alignment.

SE_793147 AC page 6 / 6