Wright Medical Technology FUSEFORCE User Manual

FUSEFORCE

Hand Fixation System

SURGICAL TECHNIQUE

®

Contents

Chapter 1 3

Chapter 2 4

Appendix A 7

Intended Use

Surgical Technique

Ordering Information
Indication Sizing Reference

Proper surgical procedures and techniques are the responsibility of the medical professional. The following
guidelines are furnished for information purposes only as techniques used by the design surgeons. Each
surgeon must evaluate the appropriateness of the procedures based on his or her personal medical
training and experience. Prior to use of the system, the surgeon should refer to the product package
insert for complete warnings, precautions, indications, contraindications and adverse eects. Package
inserts are also available by contacting Wright Medical Technology, Inc. Contact information can be
found on the back of this surgical technique, and the package insert is available at www.wmt.com.

Please contact your local Wright representative for product availability.

Intended Use

1

1

chapter

Indications

The FUSEFORCE® Implant System is intended to be used for fracture and
osteotomy fixation and joint arthrodesis of the hand and foot.

Contraindications

General contraindications for the use of these implants for joint reconstruction,
osteotomy or fusion include:

» Significant bone demineralization.

» Inadequate neurovascular status.

» Inadequate skin or musculotendinous system.

» Inadequate bone stock.

» Psychologically unsuitable patient.

» Possibility for conservative treatment.

» Bone, musculature, tendons, or adjacent soft tissue compromised by disease,

infection, or prior implantation, which cannot provide adequate support or
fixation for the prosthesis.

» Known metal allergy.

» Diabetes.

» Active infection.

Warnings

Patients should be made aware of the increased potential for device failure
when excessive demands are made upon it. Strenuous loading, excessive
mobility, and articular instability all may lead to accelerated wear and eventual
failure by loosening, fracture, or dislocation of the device.

» If excessive loading cannot be prevented, an implant should not be used.

» Abnormal or excessive forces could lead to delayed union, non-union, or

failure of the implant.

» This device has not been evaluated for safety and compatibility in the MR

environment.

» This device has not been tested for heating or migration in the MR

environment.

Prior to use of the system, the surgeon should refer to the product Instructions For Use package
insert for warnings, precautions, indications, contraindications and adverse eects. Instructions
For Use package inserts are also available by contacting the manufacturer. Contact information
can be found on the back of this surgical technique and the Instructions For Use package inserts
are available on wmt.com under the link for Prescribing Information.

3Chapter 1 Description of ChapterChapter 1 Intended Use