HALL SURGICAL BUR GUARD, MEDIUM

Description of Event or Problem

THE USER REPORTED THAT DURING THE END OF THE PROCEDURE, THE HANDPIECE IN USE WITH THIS BUR GUARD FELT HOT NEAR THE COLLET END. THE USER DID NOT NOTE EXCESSIVE HEAT IN THE BUR GUARD DURING THIS EVENT. THE USER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THE SAME HANDPIECE AND BUR GUARD WITHOUT ANY INJURIES.

Additional Manufacturer Narrative

INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THE BUR GUARD USED DURING THIS EVENT. TESTING OF THIS BUR GUARD COULD NOT BE COMPLETED AS THE TEST BUR WOULD NOT INSERT INTO THE DEVICE BECAUSE THE INNER BEARING RACE WAS OUT OF POSITION. THE USER MANUAL GIVES THE FOLLOWING INSTRUCTIONS: AS CERTAIN INTERNAL COMPONENTS (I.E. BEARINGS) ARE KNOWN TO DEGRADE WITH USE, CLEANING, STERILIZATION CYCLES, AND/OR LACK OF PREVENTATIVE MAINTENANCE, CONMED LINVATEC RECOMMENDS THAT THE SURGAIRTOME TWO HANDPIECES BE RETURNED TO THE FACTORY FOR ROUTINE MAINTENANCE EVERY TWELVE (12) MONTHS. LIKEWISE, BUR GUARDS AND ANGLE ATTACHMENTS SHOULD BE RETURNED EVERY SIX (6) MONTHS FOR PREVENTIVE MAINTENANCE. FAILURE TO FOLLOW THIS ROUTINE MAINTENANCE SCHEDULE MAY RESULT IN OVERHEATING OR DAMAGE TO THE HANDPIECE AND/OR BUR GUARD AND ATTACHMENTS, AND MAY RESULT IN INJURY TO PTS OR THE MEDICAL PERSONNEL. TO REDUCE THE RISK OF INJURY, CONMED LINVATEC RECOMMENDS THE FOLLOWING SAFETY PRECAUTIONS: PRIOR TO SURGERY: REMOVE THE BUR GUARD FROM THE DRILL AND SPIN THE BUR GUARD ON A BUR; IF THE BUR GUARD SPINS FREELY, THE BEARING IS STILL GOOD. OTHERWISE, THE BUR GUARD MUST BE SENT FOR REPAIR IMMEDIATELY. DO NOT USE. PRIOR TO USE WITH THE BUR GUARD AND BUR LOCKED SECURELY INTO THE HANDPIECE, RUN THE DRILL AND MONITOR FOR OVERHEATING. DURING USE: IT IS RECOMMENDED THAT ALL PARTS OF THE INSTRUMENT OR ITS ATTACHMENTS BE CONTINUALLY CHECKED FOR OVERHEATING. IF OVERHEATING IS NOTICED, DISCONTINUE USE AND RETURN THE EQUIPMENT FOR SERVICE. THE DRILL WAS REPORTED ON MDR 1017294-2008-00121.