General Precautions - Orthofix AGILE NAIL Gebrauchsanweisung

12. Choose the type of distal screw according to the inserted nail:
• to lock a cannulated nail distally, use only 4.0mm threaded locking screws (Code: T8340XX)
• to lock a 7mm solid nail distally, use only 3.2mm peg screws (Code: T8330XX)
13. Make sure to remove all locking screws prior to nail removal

GENERAL PRECAUTIONS

1. Ensure that all components needed for the operation are available in the operating theatre.
2. Examine all components carefully prior to use. Product integrity, sterility (in the case of sterile products) and performance are assured only if the packaging is undamaged.
3. Be careful in the handling and storage of the components. The implants should not be scratched, notched or otherwise damaged as these may reduce the functional strength of the component.
4. Check the fit and functioning of nail and instruments assembly prior to implantation.
5. Take care to assemble all components correctly and to lock them securely.
6. Cannulated instruments should be inspected prior to use to confirm that the cannulation is free from obstruction. The correctly sized wire should be passed through it, making sure that it slides easily.
7. During the introduction of any instrument or implant over a wire, the wire tip should be screened, using fluoroscopy, to exclude inadvertently driving the wire further than intended. This is particularly
important when the wires are pointing towards potentially dangerous locations, such as the physis.
8. For screws extraction take care to revert the power drill to avoid advancing them towards potentially dangerous locations.
9. Take care to achieve and maintain a correct reduction throughout the procedure.
10. Fracture distraction for any time should be avoided during the operation, and fractures should never be locked in distraction, since this may cause delayed union and/or compartment syndrome.
11. Under fluoroscopy, verify that the 3.2mm guide wire position allows adequate clearance on the lateral side of the femur for the opening awl and for the entry reamer.
12. If the 3.2mm guide wire used for opening the entry point is damaged or bent, a new guide wire must be used for insertion of the proximal reamer.
13. The entry reamer tip should be screened to avoid inadvertently driving the reamer further than intended (pay particular attention not to ream further than the medial cortex).
14. Under fluoroscopy, verify fracture reduction and the final position of the guide wire with olive to exclude inadvertently damaging the distal femoral physis.
15. Nail and proximal screw positioning must be selected after reduction of the fracture or creation of the osteotomy.
16. Depending on the position of the nail and bone anatomy, it is recommended to direct the tip of the proximal screw towards the lesser trochanter, avoiding as much as possible damaging the physis.
17. Choose the appropriate size and position of nail and screws according to the fracture pattern and patient characteristics. Improper positioning of nail and screws may result in loosening, bending, cracking,
or fracture of the device or bone or both.
18. The diameter of the selected nail should be smaller than narrowest part of the medullary canal.
19. When selecting the nail length, it is mandatory to avoid crossing the distal physis. Back-hammering to close a fracture gap and/or dynamization must be taken into account. A shorter nail should
be considered when back hammering or dynamization is planned.
20. If necessary, progressively enlarge the femoral canal with the flexible reamer at least 1.0mm greater than the selected nail diameter. Reaming in 0.5mm increments is recommended.
21. Ensure the used cannulated flexible reamer system is compatible with the 2.8mm guide wire with olive.
22. Advance the flexible reamer with steady, moderate pressure. Do not force the reamer. Partially retract the reamer often to clear debris from the medullary canal.
23. The reamer tip should be screened, using fluoroscopy, to exclude inadvertently damaging the distal femoral physis.
24. After reaming, check the guide wire with olive using fluoroscopy: if the guide wire is damaged or bent, the use of a new guide wire is mandatory for cannulated nail insertion.
25. The check of proximal screw insertion in the hole of the nail trough the targeting handle is always recommended before inserting the nail in the femur.
26. Hammering should always be gentle; vigorous hammering should never be necessary. The surgeon should never persist with hammering if the implant is not advancing, but should review the situation,
and consider further reaming.
27. Choosing the appropriate length for the proximal locking screws is critical for the effective and safe fixation. The length of the screws should be determined by using the dedicated instruments as described
in the operative technique.
28. To avoid mistake in choosing the proximal screw length, whether the 3.2mm guide wire is damaged or bent by previous usages, the use of a new guide wire is mandatory.
29. The tip of the 3.2mm guide wire and the graduated drill bit should not protrude more than 2mm to 4mm beyond the far cortex. Care should be taken not to excessively penetrate the soft tissue to avoid
possible neurovascular damages.
30. To avoid mistake in choosing the proximal screw length, the tip of the trocar must go flat against the bone and the sizing gauge must go flat against the trocar.
31. After proximal screw length measurements, make sure to hold the targeting handle in the same position: any movement of the targeting handle may result in mismatching between the drill bit and the hole.
32. Overtightening of the screw should be avoided and the head of the screw should come just in contact with the cortex. Stop insertion when resistance is felt.
33. To avoid mistake in choosing the distal screw length, the distal tissue guide must be correctly orientated to go flat against the bone.
34. Before definitively locking the nail, re-verify the reduction and correct alignment of the fragments and leg length.
35. To avoid heterotopic ossification around the head of the nail, end cap is advised.
36. If callus is slow to or fails to develop, the implant may eventually break due to metal fatigue: to avoid this, further measures may be required, including dynamization to promote callus formation
or replacement of the implant.
37. When appropriate the implants should be removed at conclusion of treatment.
38. Do not use the screw extractor on power.
39. To prevent rotation or over insertion of the nail, insert the mallet adaptor before removing the locking screws.
POSSIBLE ADVERSE EFFECTS
1. Early or late infection, both deep and superficial.
2. Delayed union, non-union, malunion, malalignment, increased fibrous tissue response.
3. Stiffness, loss of range of motion, limp, leg length discrepancy.
4. Intrinsic risks associated with anesthesia and surgery, including, but not limited to:
• pain, heterotopic ossification at the surgery site;
• vascular disorders such as compartment syndrome, avascular necrosis, thromboembolic events and fat embolism;
• damage to the growth plate with consequent growth disturbance.
5. Complications associated with metal sensitivity.
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