Contraindications; General Warnings - Orthofix AGILE NAIL Gebrauchsanweisung

PQ ANS C 05/18
EN
DESCRIPTION
The Agile Nail is designed to address femoral fractures and deformity correction procedures. The Agile Nail System consists of antegrade intramedullary nails for the femur with respective end-caps and locking
screws. The intramedullary nails feature proximal and distal holes to accept locking screws. Nails, end-caps and screws are available in several sizes and are manufactured from a titanium alloy. All implantable
devices are designed for single use only.
INDICATIONS FOR USE
The Agile Nail is intended for insertion in the medullary canal of a femur for the alignment and the stabilization of fractures and for the correction of deformities. It is indicated for the treatment of subtrochanteric
fractures and of femoral shaft fractures, in pediatric patients, with the exception of newborns and infants, and in adult patients with an appropriate medullary canal.
The indications include:
- prophylactic nailing of impending pathologic fractures;
- fixation of femurs that have been surgically prepared (osteotomy);
- nonunions and malunions;
- reconstruction following tumor resection and grafting and bone lengthening and shortening.
NOTES FOR USE
The product is intended for professional use only. Surgeons who supervise the use of the product must have full awareness of orthopaedic fixation procedures. Prior to surgery, surgeons 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

The Agile Nail is not designed or sold for any use except as indicated.
Use of the intramedullary nailing implant is contraindicated for patient 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, test should be made prior to implant insertion);
• mental or physiological conditions who are unwilling or incapable of following postoperative care instructions;
• pathological fractures without a diagnosis.

GENERAL WARNINGS

1. It is essential that the operative technique as supplied by Orthofix be followed for implantation.
2. Do not combine Agile Nail implantable components with those from other systems, unless specified.
3. Do not use if packaging is compromised or if a component is believed to be faulty, damaged or suspect.
4. Nails, end caps and screws must not be reused. If any implant has come into contact with any body fluid, it should be considered to have been used. In case repositioning of implants is required, new implants
should be used.
5. Loosening, bending, 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. The lateral aspect of the greater trochanter as an entry point is mandatory to decrease the probability of damaging the medial circumflex artery and aids in decreasing the risk of avascular necrosis of the
femoral head.
8. The nails are labeled "LEFT" or "RIGHT" on the proximal nail end: ensure to select the appropriate nail according to the leg to be treated.
9. Do not hammer directly on the targeting handle. Hammering of the nail must only be performed through the impaction rod assembled on the targeting handle.
10. The nail must be locked with only one proximal locking screw, inserted in either the transverse or the oblique hole. The transverse and the oblique proximal locking screws are convergent and must not be
inserted together.
11. For proximal locking of the nail, use only a 4.0mm threaded locking screw (Code: T8340XX). Peg screws (Code: T8330XX) must not be used for proximal locking.
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
ORTHOFIX® AGILE NAIL™
Via delle Nazioni 9 - 37012 Bussolengo (VR) Italy
Tel. 0039 (0) 45 6719000 - Fax 0039 (0) 45 6719380
Orthofix Srl
0123
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