BUR GUARD, MEDIUM

Additional Manufacturer Narrative

THE RETURNED USED DEVICE, ITEM 00137501200 WAS TESTED AND "CONFIRM" THE REPORTED PROBLEM OF THE DEVICE GOT HOT DURING CASE. AFTER ONE MINUTE OF RUN TEST THE TEMPERATURE WAS RECORDED TO 205F. EXAMINATION FOUND CORROSION INSIDE THE UNIT. ALSO, THE INNER RACE BEARING WAS BROKEN AND OUT OF THE POSITION. 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 ONE COMPLAINT, REGARDING ONE 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 0.0001. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: WARNINGS: 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. GUARDS ARE TO BE RETURNED TO LINVATEC/HALL SURGICAL EVERY SIX MONTHS FOR ROUTINE MAINTENANCE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

Description of Event or Problem

THE CUSTOMER REPORTED THAT 00137501200, BUR GUARD, MEDIUM, DEVICE BURNED A PATIENT LIP DURING AN ORAL SURGERY PROCEDURE. FURTHER INFORMATION WAS REQUESTED FROM THE REPORTING ACCOUNT; HOWEVER, TO DATE NO FURTHER INFORMATION HAS BEEN RECEIVED. A GOOD FAITH EFFORT WAS ATTEMPTED TO GAIN FURTHER INFORMATION. THE PATIENT WAS REPORTED AS INJURED BUT THE DEGREE OF BURN IS UNKNOWN. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY.