Possible Adverse Effects; Important; Mri Safety Information - Orthofix MJ-FLEX The New Metaizeau Nail Instructions D'utilisation

13. For optimal control of the nail, make sure that one jaw of the chuck is positioned exactly over the flat part of the nail;
14. During insertion, check the progression of the nail under fluoroscopy to ensure the tip is advancing without any impediment. If the implant is not advancing properly, the surgeon should never persist in the
insertion, but should review the situation and consider the following options:
- make sure the tip of the nail has the proper orientation;
- increase the contour angle near the tip of the nail;
- gently hammering the nail;
- change the nail for the next-smaller diameter;
15. Vigorous hammering should never be necessary. The nail should advance blow by blow. If the nail does not advance properly, the surgeon should never persist with hammering;
16. Make sure not to twist the tip of the second nail more than 180° to avoid the second nail spiral up around the first nail ("corkscrew effect");
17. Under fluoroscopy, verify the final position of the tip of the nail to prevent inadvertent damage to the physis. It is recommended to stop nail insertion at least 1cm before the physis to allow adequate clearance
for optional final impaction of the nail;
18. Before cutting the nail, release traction and confirm bone rotation and bone alignment under fluoroscopy in two planes to avoid malalignment;
19. Improper positioning of the nails may result in loosening, cracking, or fracture of the device or bone or both;
20. Multiple re-positioning of the nail may lead to poor anchoring of the nail tip;
21. Ensure to select the appropriate cutter and cutter hole according to the selected diameter of the nail;
22. Ensure to select the appropriate impactor according to the selected diameter of the nail;
23. 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 replacement of the implant;
24. When appropriate the implants should be removed at conclusion of treatment.

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:
• Soft tissue irritation and/or inflammation;
• Nerve damage;
• pain, heterotopic ossification at the surgery site;
• vascular disorders such as compartment syndrome, thromboembolic events;
• Damage to the growth plate with consequent growth disturbance.
5. Complications associated with metal sensitivity.
6. Hardware migration/displacement with or without skin or joint perforation.
7. Loss of reduction.
8. Refracture.

IMPORTANT

A successful result is not achieved in every surgical case. Additional complications may develop at any time due to improper use, medical reasons or device failure that require surgical re-intervention to remove
or replace the internal fixation device.
Preoperative and operative procedures including knowledge of surgical techniques and proper selection and placement of the device are important considerations in the successful utilization of the devices
by the surgeon.
Proper patient selection and the patient's ability to comply with physician instructions and follow the prescribed treatment regimen will greatly affect the results. It is important to screen patients and select
optimal therapy given physical and/or mental activity requirements and/or limitations. If a surgical candidate exhibits any contraindication or is predisposed to any contraindication, DO NOT USE the ORTHOFIX
MJ Flex Nail.

MRI SAFETY INFORMATION

ORTHOFIX MJ Flex Nail has not been evaluated for safety and compatibility in the MR environment.
It has not been tested for heating, migration, or image artifact in the MR environment. The safety of The ORTHOFIX MJ Flex Nail in the MR environment is unknown. Scanning a patient who has this device may
result in patient injury.
INFORMATION
Instructions for processing and reprocessing
These instructions apply to Orthofix MJ Flex Nail system fixation devices and instruments.
These reprocessing instructions were written in accordance with ISO17664 and have been validated by Orthofix in compliance with international standards. It is the responsibility of the health care facility to ensure
that the reprocessing is performed in accordance with instructions and to perform validation and routine monitoring of the process. Any deviation from these instructions is responsibility of the health care
facility in charge of reprocessing.
STERILE & NON-STERILE Product
Orthofix provides certain devices STERILE while others are provided NON-STERILE. Please review the product label to determine the sterility of each device.
Sterile
Devices or kits provided STERILE are labeled as such. Contents of package are STERILE unless package is opened or damaged. Do not use if package is opened or damaged.
3