BUR GUARD, LONG

Additional Manufacturer Narrative

THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

Description of Event or Problem

THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 00137501100, BUR GUARD, LONG WAS BEING USED ON (B)(6) 2022 DURING AN ORAL SURGERY BURRING AND THE DEVICE ¿HEATED UP AND BURNT PATIENTS CHEEK¿. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT HAND PIECE AND BUR GUARD AND THERE WAS A 30 MINUTE DELAY TO THE PROCEDURE. THE PATIENT STATUS WAS REPORTED AS ¿GOOD¿. FURTHER ASSESSMENT FOUND, IT IS NOT KNOWN IF TREATMENT WAS GIVEN OR WHAT DEGREE OF BURN WAS RECEIVED. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO UNKNOWN DEGREE OF BURN.

Description of Event or Problem

THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 00137501100, BUR GUARD, LONG WAS BEING USED ON 24JAN22 DURING AN ORAL SURGERY BURRING AND THE DEVICE ¿HEATED UP AND BURNT PATIENTS CHEEK ¿. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT HAND PIECE AND BUR GUARD AND THERE WAS A 30 MINUTE DELAY TO THE PROCEDURE. THE PATIENT STATUS WAS REPORTED AS ¿GOOD¿. FURTHER ASSESSMENT FOUND, IT IS NOT KNOWN IF TREATMENT WAS GIVEN OR WHAT DEGREE OF BURN WAS RECEIVED. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO UNKNOWN DEGREE OF BURN.

Additional Manufacturer Narrative

REPORTED EVENT OF DEVICE BURNING PATIENT IS INCONCLUSIVE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AND NO PHOTOGRAPHIC EVIDENCE HAS BEEN PROVIDED; THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 1 REPORT, REGARDING 1 DEVICE, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 10,272 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 0.0001. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: INSPECT FOR DULL AND/OR CHIPPED CUTTING SURFACES ON THE BUR. USE OF DULL BURS MAY CAUSE HEAT BUILDUP, ADD TIME TO THE PROCEDURE AND/OR CAUSE THERMAL DAMAGE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.