HALL SURGICAL BUR GUARD, MEDIUM

Description of Event or Problem

THE CUSTOMER REPORTED THAT THIS BUR GUARD WAS IN USE WHEN THE HANDPIECE GENERATED HEAT IN THE AREA OF THE COLLET. THE USER EXCHANGED OUT THIS DEVICE FOR AN ALTERNATE AND COMPLETED THE SURGERY WITHOUT SERIOUS INJURY OR SURGICAL DELAY.

Additional Manufacturer Narrative

INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS BUR GUARD FOR EVALUATION AND DID NOT CONFIRM THE REPORTED PROBLEM. DURING TESTING OF THIS UNIT, IT FUNCTIONED TO SPECIFICATION. FURTHER INVESTIGATION FOUND THE BUR GUARD OVER DUE FOR PREVENTATIVE MAINTENANCE; NO PRIOR REPAIR HISTORY NOTED. THE INFO FOR USE (IFU) WARNS THE USER OF 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 EVERY SIX MONTHS FOR ROUTINE MAINTENANCE. FAILURE TO FOLLOW THIS ROUTINE MAINTENANCE SCHEDULE MAY RESULT IN OVERHEATING OR DAMAGE TO THE HANDPIECE AND/OR BUR GUARD, AND MAY RESULT IN INJURY TO PTS OR THE MEDICAL PERSONNEL. BUR GUARD TEST PROCEDURE: PRIOR TO ATTACHING THE BUR GUARD; 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. 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. THE HANDPIECE REPORT FOR THIS EVENT IS SUBMITTED UNDER MDR 1017294-2008-00110.