Mj-Flex The New Metaizeau Nail - Orthofix MJ-FLEX The New Metaizeau Nail Instructions D'utilisation

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PQ MJF B 02/18

DESCRIPTION

MJ Flex is an intramedullary implant system specifically designed for Elastic Stable Intramedullary Nailing (ESIN) fracture fixation. The principle of ESIN involves balanced nailing to provide elasticity and stability

at the fracture site.

INTENDED USE

The MJ-FLEX THE NEW METAIZEAU NAIL™ is intended for the treatment of diaphyseal fractures of long bones.

INDICATIONS

The MJ-FLEX THE NEW METAIZEAU NAIL™ is indicated to treat:

- upper extremity and clavicle fractures in all patients except newborns and infants;

- lower extremity fractures in pediatric patients, except newborns and infants, where the flexibility of the implant is paramount not to disrupt the growth plate;

- lower extremity fractures in small adults where the medullary canal is narrow.

NOTES FOR USE

The product is intended for professional use only. Surgeons who supervise the use of the product must have full awareness of orthopedic fixation procedures and should be familiar with the devices, instruments

and surgical procedure, including the application and removal. Detailed operative technique guidance is available on request; please contact Orthofix or your local distributor.

CONTRAINDICATIONS

Use of the MJ-FLEX THE NEW METAIZEAU NAIL™ is contraindicated for patients with:

- general medical conditions not suitable for surgery;

- active or suspected latent infections in the fracture area;

- foreign body sensitivity (where material sensitivity is suspected, tests should be made prior to implant insertion);

- mental or physiological conditions, who are unwilling or incapable of following postoperative care instructions;

- compromised bone stock, potentially leading to inadequate or unstable fixation of the device;

- fractures with undiagnosed pathologies.

GENERAL WARNINGS

1. Preoperative procedures, knowledge of surgical technique and proper selection and placement of the implant are important aspects for the successful use of the device by the surgeon;

2. Do not combine MJ-FLEX THE NEW METAIZEAU NAIL™ with components from other systems;

3. Do not combine two nails of dissimilar metals, since this may cause an electrolytic reaction;

4. Never insert more than two nails in the same medullary canal;

5. Nails must not be reused. If any implant has come into contact with any body fluid it should be considered to have been used. Loosening, cracking or breakage of the implants can cause loss of stabilization;

6. This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine;

7. In skeletally immature patients, it is recommended to avoid crossing open epiphyseal plates to decrease the probability of consequent growth disturbance.

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. Do not use if packaging is compromised or if a component is believed to be faulty, damaged or suspect;

4. Careful handling and storage of the product is required. Scratching or damage to the component can significantly reduce the strength and fatigue resistance of the products;

5. Check the fit and functioning of nails and instruments assembly prior to implantation;

6. Ideally, two nails should be used. Where the medullary canal is very narrow, (e.g. for clavicular, metacarpal, phalangeal and metatarsal fractures), only one nail might be used taking care to fill the canal

as much as possible;

7. Ideally, the two nails should have the same diameter so that the opposing forces are equal, limiting iatrogenic valgus or varus deformities;

8. The diameter of the selected nail should be no more than 50% of the width of isthmus. In case two nails with different diameters are used, the sum of the two diameters should not be more than the width

of the isthmus;

9. The flat part of the bended nail must be on the concave side of the curve;

10. Avoid creating sharp bends. The shape of the bent nail must be a bow without any edge;

11. If the nail is bent more than planned, avoid bending it in reverse but consider bending a new nail;

12. When opening the cortex, insert the awl with moderate pressure. The tip of the awl should be screened to avoid inadvertently driving it further than intended. This is essential when the awl is pointing

towards potentially critical locations (such as the region of the femoral artery);

Instructions For Use are subject to change; the most current version of each Instruction For Use is always available online.

Important information - please read prior to use