MICROCHOICE BUR GUARD, MEDIUM

Description of Event or Problem

THE USER REPORTED THAT DURING USE OF THIS BUR GUARD WITH HANDPIECE IT GOT HOT. THE USER FELT THE HEAT IN THE BODY OF THE HANDPIECE. THE PROCEDURE WAS COMPLETED WITH THIS BUR GUARD WITHOUT INJURY.

Additional Manufacturer Narrative

INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS BUR GUARD FOR EVALUATION AND CONFIRMED THE REPORTED PROBLEM. DURING TESTING OF THIS UNIT, IT EXCEEDED THE TEMPERATURE SPECIFICATION RELATED TO WORK BEARINGS. IN ADDITION, THIS UNIT IS OVERDUE FOR PREVENTATIVE MAINTENANCE; CONMED LINVATEC REPAIR RECORDS SHOW THIS UNIT WAS LAST REPAIRED IN 10/2007. IN ADDITION, THE CUSTOMER RETURNED 3 DRILLS ((B) (4), (B) (4) & (B) (4)) FOR EVALUATION BECAUSE THE SERIAL NUMBER OF THE DRILL IN USE AT THE TIME OF THIS EVENT IS UNKNOWN. TESTING OF ALL RETURNED HANDPIECES DID NOT CONFIRM OVERHEATING. THE INFORMATION FOR USE (IFU) WARNS 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 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 PATIENTS 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.