CONMED

Additional Manufacturer Narrative

THE REPORTED DEVICE HAS BEEN RETURNED TO CONMED; HOWEVER, THE INVESTIGATION OF THE DEVICE HAS NOT BEEN COMPLETED. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE 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 (B)(6), BUR GUARD, MEDIUM WAS BEING USED DURING A WISDOM TEETH EXODONTIA ON (B)(6) 2025 AND ¿HIGH SPEED DRILL AND BUR GUARD MADE RATTLING SOUND MID PROCEDURE, SO THE BUR GUARD WAS SWAPPED FOR A NEW UNIT AND TESTED FOR FUNCTION. PROCEDURE RESUMED. DRILL AND BUR GUARD GOT HOT IMMEDIATELY AND CAUSED BURN TO PATIENTS LIP AND SURGEONS HAND¿ THE DEGREE OF THE BURN WAS NOT ASSESSED OR RECORDED. THERE IS A PHOTO AVAILABLE UPON REQUEST. PATIENT INJURY: LOWER LIP AND VERMILLION BORDER, RIGHT HAND SIDE - BURNED, SIZE OF AREA =2CM. USER/SURGEON INJURY: RIGHT INDEX FINGER AND WEBBING BETWEEN RIGHT INDEX FINGER AND RIGHT THUMB MILD BURN. THE PATIENT'S TREATMENT WAS: SURGEON IRRIGATED PATIENT'S LIP WITH SALINE, AND SIGMACORT WAS APPLIED. SURGEON COMPLETED REVIEW APPOINTMENTS TO MONITOR THE HEALING PROCESS. NO TREATMENT FOR THE SURGEON'S HAND.¿ THE PHOTO WAS REQUESTED AND TO DATE HAS NOT BEEN RECEIVED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH ALL 4 WISDOM TEETH EXTRACTED AND THERE WAS A 5-MINUTE DELAY. THE PRO7000SE, HALL MICROPOWER+ HIGH SPEED DRILL WILL BE LISTED AS A CONCOMITANT DEVICE AND THERE IS NO ALLEGATION AGAINST IT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF BURNS TO THE PATIENT AND SURGEON.

Additional Manufacturer Narrative

REPORTED EVENT ¿DRILL AND BUR GUARD GOT HOT IMMEDIATELY AND CAUSED BURN TO PATIENT¿S LIP AND SURGEON¿S HAND¿ WAS UNCONFIRMED. HOWEVER, THE BEARING WAS BROKEN. THE UNIT IS UNREPAIRABLE AND REQUIRES A REPLACEMENT. THE SERVICE HISTORY WAS REVIEWED, AND NO DATA WAS FOUND. 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. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF (B)(4) REPORT, REGARDING (B)(4) DEVICE, 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: PRIOR TO EACH USE, ALL EQUIPMENT MUST BE INSPECTED FOR PROPER OPERATION. OVERHEATING MIGHT OCCUR IF BEARINGS ARE WORN OR ARE NOT KEPT CLEAN. IF OVERHEATING OCCURS, DISCONTINUE USE AND RETURN FOR SERVICE. 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.

Description of Event or Problem

THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 00137501200, BUR GUARD, MEDIUM WAS BEING USED DURING A WISDOM TEETH EXODONTIA ON (B)(6) 2025 AND ¿HIGH SPEED DRILL AND BUR GUARD MADE RATTLING SOUND MID PROCEDURE, SO THE BUR GUARD WAS SWAPPED FOR A NEW UNIT AND TESTED FOR FUNCTION. PROCEDURE RESUMED. DRILL AND BUR GUARD GOT HOT IMMEDIATELY AND CAUSED BURN TO PATIENTS LIP AND SURGEONS HAND¿ THE DEGREE OF THE BURN WAS NOT ASSESSED OR RECORDED. THERE IS A PHOTO AVAILABLE UPON REQUEST. PATIENT INJURY: LOWER LIP AND VERMILLION BORDER, RIGHT HAND SIDE - BURNED, SIZE OF AREA =2CM. USER/SURGEON INJURY: RIGHT INDEX FINGER AND WEBBING BETWEEN RIGHT INDEX FINGER AND RIGHT THUMB MILD BURN. THE PATIENT'S TREATMENT WAS: SURGEON IRRIGATED PATIENT'S LIP WITH SALINE, AND SIGMACORT WAS APPLIED. SURGEON COMPLETED REVIEW APPOINTMENTS TO MONITOR THE HEALING PROCESS. NO TREATMENT FOR THE SURGEON'S HAND.¿ THE PHOTO WAS REQUESTED AND TO DATE HAS NOT BEEN RECEIVED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH ALL 4 WISDOM TEETH EXTRACTED AND THERE WAS A 5-MINUTE DELAY. THE PRO7000SE, HALL MICROPOWER+ HIGH SPEED DRILL WILL BE LISTED AS A CONCOMITANT DEVICE AND THERE IS NO ALLEGATION AGAINST IT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF BURNS TO THE PATIENT AND SURGEON.