CONMED

Description of Event or Problem

THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 16.1018, SUTURE RETRIEVAL FORCEPS, ARTHROSCOPIC, 3.4 MM X 130 MM, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿SUTURE GRASPER BROKE IN PATIENT DURING SURGERY. BROKEN PIECE RETRIEVED ¿ YES.¿. IT WAS REPORTED THAT AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF A DELAY IN THE PROCEDURE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. 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 PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

Description of Event or Problem

THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 16.1018, SUTURE RETRIEVAL FORCEPS, ARTHROSCOPIC, 3.4 MM X 130 MM, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿SUTURE GRASPER BROKE IN PATIENT DURING SURGERY. BROKEN PIECE RETRIEVED ¿ YES.¿ IT WAS REPORTED THAT AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF A DELAY IN THE PROCEDURE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

Additional Manufacturer Narrative

NEITHER THE DEVICE NOR PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. A DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED AS A SERIAL NUMBER WAS NOT PROVIDED. ALTHOUGH THIS IS A REUSABLE DEVICE, IT IS NOT SERVICEABLE. THEREFORE, A SERVICE HISTORY IS NOT AVAILABLE FOR REVIEW. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 3 COMPLAINTS, REGARDING 3 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) 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 (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THAT PRIOR TO USE, CLEANING, DISINFECTION, OR STERILIZATION, REMOVE ALL PROTECTIVE PACKAGING AND TIP PROTECTOR, IF APPLICABLE. INSPECT 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 PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.