BUR GUARD, LONG
Received May 28, 2008 · Event occurred May 8, 2008
Report 1017294-2008-00209 · MDR key 1054687
Device
Generic name
Bur Guard
Manufacturer
Conmend LinvatecModel number
NACatalog number
00137501100
Lot number
MAY07S
Product problems
- Mechanical Problem
- Overheating of Device
Patient
NK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT DURING USE OF THIS BUR GUARD, THE DEVICE WAS MAKING A FUNNY NOISE AND GOT HOT. AN ALTERNATE BUR GUARD WAS USED WITH THE SAME DRILL TO COMPLETE THE PROCEDURE AS INTENDED. THERE WAS NO INJURY OR SIGNIFICANT SURGICAL DELAY RELATED TO THIS EVENT.
Additional Manufacturer Narrative
INVESTIGATION FINDINGS: AN EVALUATION OF THE DEVICE CONFIRMED THE REPORTED PROBLEM OF OVERHEATING RELATED TO BEARING FAILURE. FURTHER INVESTIGATION FOUND THE DEVICE OVERDUE FOR PREVENTATIVE MAINTENANCE; LAST DATE OF REPAIR MAY 2007. THE DRILL IN USE WITH THIS BUR GUARD WAS NOT RETURNED FOR INVESTIGATION. THE USER REPORTED THAT PRE-TESTING OF INSTRUMENTS IS PERFORMED, THE DEVICES ARE MONITORED FOR HEAT DURING USE AND THEY ARE AWARE OF THE PREVENTIVE MAINTENANCE SCHEDULE. IN ADDITION, THE CUSTOMER REPORTED THEY KNOW HOW TO PERFORM BUR GUARD TESTING. 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 THIS BUR GUARD 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, ANY 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.