HALL SURGICAL BUR GUARD, MEDIUM

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF THIS BUR GUARD, IT GOT HOT. THE HEAT WAS FELT BY THE USER WHICH PROMPTED DISCONTINUED USE OF THE BUR GUARD AND HANDPIECE. THE CUSTOMER REPORTED THAT ANOTHER UNIT WAS OBTAINED TO COMPLETE THE PROCEDURE AS INTENDED. THERE WAS NO INJURY OR SURGICAL DELAY REPORTED WITH THIS EVENT.

Additional Manufacturer Narrative

INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS BUR GUARD FOR EVALUATION AND WAS UNABLE TO CONFIRM THE REPORTED PROBLEM BECAUSE THE UNIT WAS RECEIVED INOPERABLE. FURTHER INVESTIGATION FOUND THE BUR GUARD BEARING BROKEN AND LOOSE. IN ADDITION, THIS UNIT IS OVERDUE FOR PREVENTIVE MAINTENANCE. LAST DATE OF REPAIR DOCUMENTED WAS OCTOBER 2007. ASSOCIATED REPORT: 1017294-2008-00268. THE INFORMATION 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/HALL SURGICAL EVERY SIX MONTHS FOR ROUTINE MAINTENANCE. 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 FOR SERVICE. THE CUSTOMER WILL BE PROVIDED ADDITIONAL INFORMATION ON THE CARE AND HANDLING OF THIS DEVICE.