CONMED

Additional Manufacturer Narrative

REPORTED EVENT OF THE DEVICE BREAKING OFF INTO THE PATIENT IS CONFIRMED. THE DEVICE IS NOT BEING RETURNED; HOWEVER, PHOTOGRAPHIC EVIDENCE HAS BEEN PROVIDED. THE ROOT CAUSE CANNOT BE DETERMINED; HOWEVER, BASED UPON THE PHOTO AND THE IFU, THE LIKELY CAUSE OF THIS EVENT WAS EXCESSIVE FORCE THAT BROKE THE DEVICE OVER REPEATED USES. THE SERVICE HISTORY WAS REVIEWED, AND NO DATA WAS FOUND. A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE AS THE RECORD COULD NOT BE LOCATED WITHIN THE SYSTEM. NC-14290 WAS CREATED TO DOCUMENT THE MISSING DHR RECORD AND ACTIVITIES ASSOCIATED WITH THIS NON-CONFORMANCE. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 6 REPORTS, REGARDING 6 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 87,157 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE 0.00007. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: INSPECT THE INSTRUMENT PRIOR TO USE TO ENSURE IT IS IN GOOD PHYSICAL CONDITION AND FUNCTIONS PROPERLY. THERE SHOULD BE NO LOOSE, BROKEN OR MISALIGNED PARTS. EXERCISE CARE IN THE USE OF THE DEVICE TO MINIMIZE SIDE OR BENDING LOADS. DO NOT USE EXCESSIVE FORCE ON INSTRUMENTS TO AVOID DAMAGE OR BREAKAGE DURING USE. AVOID UNINTENDED CONTACT WITH OTHER SURGICAL INSTRUMENTS DURING USE TO PREVENT DAMAGE OR BREAKAGE. INSPECT INSTRUMENT AFTER USE TO ENSURE IT HAS NOT BEEN DAMAGED. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

Description of Event or Problem

THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 25.50014, 4.5MM X 150MM LIBERATOR KNIFE, WAS BEING USED ON 1JUL24 DURING A ROTATOR CUFF REPAIR AND "DURING THE OPERATION THE DOCTOR USED THE INSTRUMENT NORMALLY AND THEN PART OF THE INSTRUMENT BROKE." PER FURTHER ASSESSMENT IT WAS FOUND THAT THE DEVICE FRAGMENT FELL INTO THE SURGICAL SITE AND "THE DEVICE WAS RETRIEVED WITH NO COMPLICATIONS". THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE RASP AND THERE WAS NO DELAY. THERE WAS NO IMPACT OR INJURY FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

Additional Manufacturer Narrative

THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

Description of Event or Problem

THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 25.50014, 4.5MM X 150MM LIBERATOR KNIFE, WAS BEING USED ON (B)(6) 2024 DURING A ROTATOR CUFF REPAIR AND "DURING THE OPERATION THE DOCTOR USED THE INSTRUMENT NORMALLY AND THEN PART OF THE INSTRUMENT BROKE." PER FURTHER ASSESSMENT IT WAS FOUND THAT THE DEVICE FRAGMENT FELL INTO THE SURGICAL SITE AND "THE DEVICE WAS RETRIEVED WITH NO COMPLICATIONS". THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE RASP AND THERE WAS NO DELAY. THERE WAS NO IMPACT OR INJURY FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.