BUR GUARD, MEDIUM

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. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

Description of Event or Problem

THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 00137501200, BUR GUARD, MEDIUM WAS BEING USED ON (B)(6) 2023 DURING A TEETH REMOVAL PROCEDURE AND ¿A BUR GUARD OVERHEATED AND CAUSED INJURY TO THE PATIENT¿S LIP, THE EXTENT IS YET TO BE DETERMINED. WHEN PLACED ON THE DRAPE IT MELTED ONTO THE BUR GUARD ITSELF. THE SURGEON FELT NO HEAT RADIATION INTO THE HANDPIECE. THE BUR WAS EASILY REMOVED AS WAS THE BUR GUARD¿. THE PROCEDURE WAS COMPLETED AND THERE WAS NO DELAY. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO UNKNOWN DEGREE OF BURN TO THE PATIENT¿S LIP.

Description of Event or Problem

THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 00137501200, BUR GUARD, MEDIUM WAS BEING USED ON (B)(6) 2023 DURING A TEETH REMOVAL PROCEDURE AND ¿A BUR GUARD OVERHEATED AND CAUSED INJURY TO THE PATIENT¿S LIP, THE EXTENT IS YET TO BE DETERMINED. WHEN PLACED ON THE DRAPE IT MELTED ONTO THE BUR GUARD ITSELF. THE SURGEON FELT NO HEAT RADIATION INTO THE HANDPIECE. THE BUR WAS EASILY REMOVED AS WAS THE BUR GUARD¿. THE PROCEDURE WAS COMPLETED AND THERE WAS NO DELAY. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO UNKNOWN DEGREE OF BURN TO THE PATIENT¿S LIP.

Additional Manufacturer Narrative

AN EVALUATION OF THE RETURNED DEVICE FOUND THAT THE BEARING COLLAPSED AND DAMAGED ¿ UNREPAIRABLE. THE COLLAPSED BEARING IS KNOWN TO INCREASE FRICTION, AND SUBSEQUENTLY INCREASING THE OPERATING TEMPERATURE OF THE DEVICE. 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. 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 REPORTS, 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 THE FOLLOWING: OVERHEATING MIGHT OCCUR IF BEARINGS ARE WORN OR ARE NOT KEPT CLEAN. IF OVERHEATING OCCURS, DISCONTINUE USE AND RETURN FOR SERVICE. PRIOR TO ATTACHING THE BUR GUARD: A) CHECK FOR WORN BEARINGS BY INSERTING A BUR INTO THE NOSE OF THE BUR GUARD. WHILE HOLDING THE BUR, SPIN THE GUARD. THE GUARD SHOULD SPIN FREELY AROUND THE BUR SHAFT WITHOUT RESTRICTIONS. B) ATTACH THE BUR AND GUARD TO THE DRILL USING THE FOLLOWING INSTRUCTIONS. RUN THE INSTRUMENT FOR AT LEAST 30 SECONDS, CAREFULLY FEELING THE TIP OF THE GUARD FOR HEAT. IF HEAT IS NOTICED, DISCONTINUE USE AND RETURN TO LINVATEC/HALL SURGICAL FOR SERVICE WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.