COFIX POSTERIOR MIS FUSION SYSTEM

Additional Manufacturer Narrative

A VISUAL INSPECTION OF THE RETURNED SYSTEM INSERTER SHOWED AN INSTRUMENT WITH REPEATED USE, AS IDENTIFIED BY SURFACE SCRATCHES, WORN LASER MARKINGS, AND IMPACT MARKS PRESENT. THE BALL HANDLE ASSEMBLY WAS SEPARATED FROM THE BODY OF THE INSTRUMENT AS REPORTED. THE PIN INTENDED TO CONNECT THE TUBE TO THE FRAME HANDLE WAS NOT PRESENT AND THE WELD THAT SECURES THE TUBE TO THE FRAME HANDLE HAD SEPARATED. IMPACT MARKS WERE IDENTIFIED ON THE FRAME FRONTSIDE AND FRAME BACKSIDE. A FUNCTIONALITY ASSESSMENT WAS NOT PERFORMED DUE TO THE DAMAGED CONDITION OF THE RETURNED SYSTEM INSERTER. THE INSTRUMENT AND REPORTED MALFUNCTION WERE PROVIDED TO THE CONTRACT MANUFACTURER ON 2/27/2025 FOR FURTHER INSPECTION AND INVESTIGATION. THE INVESTIGATION PERFORMED BY THE CONTRACT MANUFACTURER INCLUDED A DHR REVIEW, AND AN NCMR WAS IDENTIFIED AND REPORTED TO HAVE NO INFLUENCE ON THE OBSERVED INSTRUMENT MALFUNCTION. THE INSTRUMENT LOT MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. THIS LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 9/03/2020. THE COMPONENTS OF THE SYSTEM INSERTER THAT SEPARATED WERE INITIALLY CONNECTED WITH A PIN AND WELD. THE RETURNED SYSTEM INSERTER WELD WAS BROKEN, AND THE PIN WAS NOT PRESENT. REPEATED USE AND IMPACTS TO THE SYSTEM INSERTER MAY HAVE CONTRIBUTED TO THE INSTRUMENT COMPONENTS BREAKING. IT MAY BE POSSIBLE THAT REPEATED USE AND APPLIED FORCES LED TO THE OBSERVED INSTRUMENT MALFUNCTION. THERE HAVE NOT BEEN ANY OTHER COMPLAINTS OF SIMILAR NATURE IN THE PAST 12 MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR FOR REPORTS OF BROKEN SYSTEM INSERTERS AND PERFORM COMPLAINT INVESTIGATIONS.

Description of Event or Problem

THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 2/26/2025. IT WAS REPORTED THAT A SYSTEM INSERTER WAS BROKEN AND REQUESTED TO BE REPLACED. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT. THE PHYSICIAN WAS ABLE TO USE THE COMPLAINT INSTRUMENT TO SUCCESSFULLY COMPLETE THE PROCEDURE. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 3/03/2025.