HALL SURGICAL BUR GUARD, MEDIUM

Description of Event or Problem

THE CUSTOMER REPORTED THAT DURING USE OF THIS BUR GUARD WITH A DRILL, THE DRILL STARTED TO SOUND FUNNY. THE SURGEON WENT TO CHECK THE LOCK ON THE HANDPIECE AND NOTED THAT THE BUR GUARD WAS VERY HOT TO TOUCH. THE BUR GUARD WAS EXCHANGED FOR AN ALTERNATE UNIT, AND THE PROCEDURE WAS COMPLETED WITHOUT INJURY OR SURGICAL DELAY.

Additional Manufacturer Narrative

INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THE BUR GUARD FOR EVALUATION AND CONFIRMED THE REPORTED PROBLEM. DURING TESTING OF THIS BUR GUARD, IT OVERHEATED RELATED TO BEARING FAILURE. FURTHER INVESTIGATION FOUND THIS DEVICE WAS LAST SERVICED IN 2004. THE INSTRUCTIONS FOR USE (IFU) INFORM THE USER OF 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. GUARDS ARE TO BE RETURNED TO LINVATEC/HALL SURGICAL EVERY SIX MONTHS FOR ROUTINE MAINTENANCE. BUR GUARD 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 CUSTOMER WILL BE PROVIDED ADDITIONAL INFORMATION REGARDING USE OF THIS DEVICE.