INDICATIONS
The Nextremity Solutions Nextra® Hammertoe Correction Implant is indicated for small bone reconstruction limited to inter- phalangeal repair and fusion of the lesser toes.

CONTRAINDICATIONS
The Nextremity Solutions Nextra® Hammertoe Correction Implant is NOT intended for use in procedures involving the great toe. In addition, the device is contraindicated in the following:

  1. Pathological conditions of bone, such as cystic changes or severe osteopenia, osteoporosis, bony deficiencies, or comminuted bone surface which would adversely affect the Nextra® Hammertoe Correction Implant.
  2. Physical conditions that would eliminate, or tend to eliminate, adequate implant support or retard healing, including inadequate soft tissue coverage.
  3. Conditions which tend to limit the patient’s ability or willingness to restrict activities or follow directions during the healing period.
  4. Sensitivity or allergy to the metal implant.  Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.
  5. Blood supply limitations and previous infections that may retard healing.
  6. Presence of an active infection.
  7. Pediatric patients with open epiphyseal plates.

WARNINGS
This device should only be used by physicians with training in and a thorough understanding of orthopaedic surgery.

  1. The Nextra® Hammertoe Correction Implant is not designed to withstand full weight-bearing or excessive activity until healing has occurred.
  2. The Nextra® Hammertoe Correction Implant must be used with the Nextra™ Driver for proper insertion.
  3. Incomplete insertion, delayed or incomplete healing or poor bone quality may result in implant failure, loosening or bone fracture.
  4. The Nextra® Hammertoe Correction Implant is not designed to provide rotational stability between the bone segments targeted for fusion.
  5. The Nextra® Hammertoe Correction Implant is FOR SINGLE USE ONLY. DO NOT RESTERILIZE OR REUSE.
  6. Do not use in conjunction with implants of other metallic alloys.
  7. Do not use if the implant appears damaged upon inspection.
  8. The Nextra® Hammertoe Correction Implant has not been evaluated for safety and compatibility in the MR environment.  The Nextra™ Hammertoe Correction Implant has not been tested for heating or migration in the MR environment.

CAUTIONS

  1. The use of this device may not be suitable for patients with insufficient or immature bone. The physician should carefully assess the quality of the bone before performing orthopedic surgery on patients who are skeletally immature.
  2. Do not remove the inserter from the Hammertoe Correction Implant until the fixation implant is inserted and properly seated.
  3. Proper orientation and alignment of the driver is important during implantation of the Nextra® Hammertoe Correction Implant to minimize possible breakage of the fixation implant.
  4. The patient should be provided with an appropriate postoperative support or shoe, and instructions to limit weight bearing for up to six weeks.
  5. Use care to properly align the implant and driver during insertion. Do not bend or twist the inserter during or after insertion, as damage to the implant or incomplete insertion may result.
  6. Do not attempt to use a damaged implant.

POTENTIAL ADVERSE EFFECTS
Fracture of the implant as the result of excessive activity, incomplete healing or inadequate support during the healing period. Infections, both deep and superficial. Allergic reactions to device materials. Patient sensitivity to device materials must be considered prior to implantation. Device breakage or migration. Pain, discomfort or abnormal sensation due to the presence of the implant. Difficulty of removal due to bone in-growth and overgrowth.