MICROCHOICE BUR GUARD, MEDIUM

Description of Event or Problem

THE CUSTOMER REPORTED THAT DURING USE OF THIS BUR GUARD WITH HANDPIECE, IT GOT HOT. THERE WAS NO INJURY OR SURGICAL DELAY RELATED TO THIS EVENT.

Additional Manufacturer Narrative

INVESTIGATION: CONMED LINVATEC RECEIVED THIS BUR GUARD FOR EVALUATION AND CONFIRMED THE REPORTED PROBLEM. AN INVESTIGATION FOUND THE UNIT EXCEEDED MANUFACTURER TEMPERATURE SPECIFICATIONS RELATED TO A WORN BEARING ASSEMBLY. IT WAS ALSO IDENTIFIED THAT THIS BUR GUARD WAS COVERED WITH RUST LIKE DEPOSITS. A REVIEW OF SERVICE HISTORY RECORDS SHOW THAT THIS BUR GUARD HAS NO HISTORY OF REPAIR WITH A MANUFACTURE DATE OF AUGUST 2006. THE CONCOMITANT HANDPIECE WAS NOT RETURNED FOR EVALUATION. 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. THE USER WILL BE SENT ADDITIONAL INFORMATION ON CARE OF THESE DEVICES.