OSSIOFIBER® COMPRESSION STAPLE SYSTEM

Description of Event or Problem

REMOVAL SURGERY DUE TO LOCALIZED PAIN AT THE SURGICAL SITE 1.5 YEARS FOLLOWING AN AKIN OSTEOTOMY PROCEDURE. THE BRIDGE PART OF THE IMPLANT WAS REMOVED.

Additional Manufacturer Narrative

COMPANY WAS NOTIFIED OF A REMOVAL SURGERY. AN INVESTIGATION WAS PERFORMED INCLUDING INTERNAL ANALYSIS OF RECORDS AND THE SURGEON'S FEEDBACK. THE REMOVED PART COULD NOT BE EXAMINED AS IT WAS NOT PROVIDED TO THE COMPANY. NO IMAGING WAS PROVIDED. THE REMOVAL WAS COMPLETED SUCCESSFULLY. THERE IS NO INDICATION OF A DESIGN, MANUFACTURING OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS. BASED ON THE SURGEON'S FEEDBACK, IT IS CONCLUDED THAT THIS EVENT WAS THE OUTCOME OF AN INADEQUATE SURGICAL TECHNIQUE WHICH UNINTENTIONALLY RESULTED IN THE IMPLANT SITTING PROUD OVER THE BONE, CAUSING LOCALIZED PAIN. THE INSTRUCTIONS FOR USE INCLUDE PRECAUTIONS AND RECOMMENDATIONS FOR THE SELECTION OF APPROPRIATE SURGICAL TECHNIQUE, IMPLANT SIZE, CONFIGURATION, AND SURGICAL SITE PREPARATION. ALTHOUGH THE COMPANY DOES NOT BELIEVE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE INJURY, AS AN IMPLANT REMOVAL SURGERY WAS PERFORMED, THIS EVENT IS BEING REPORTED OUT OF ABUNDANCE OF CAUTION. COMPANY CONTINUES TO MONITOR THESE EVENTS AS PART OF POST MARKET ACTIVITIES. ADDITIONAL REPORT FROM THE MANUFACTURER RELATING TO THIS EVENT IS: #,