HALL SURGICAL BUR GUARD
Received Jun 16, 2008 · Event occurred May 16, 2008
Report 1017294-2008-00234 · MDR key 1062670
Device
Product problems
- Overheating of Device
Patient
NK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THIS BUR GUARD WAS USED WITH A HANDPIECE THAT OVERHEATED. THE SURGEON FELT THE HEAT AT "THE END OF THE HANDPIECE" AND DISCONTINUED USE. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE SURGERY WITHOUT SERIOUS INJURY OR SURGICAL DELAY.
Additional Manufacturer Narrative
INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS BUR GUARD FOR EVAL AND FOUND BEARING FAILURE. IN ADDITION, THIS UNIT IS OVERDUE FOR PREVENTATIVE MAINTENANCE; CONMED LINVATEC REPAIR RECORDS SHOW NO REPAIR HISTORY SINCE 1988. THE CUSTOMER DID NOT REMEMBER WHICH DRILL WAS IN USE AT THE TIME WITH THIS BUR GUARD WHEN OVERHEATING OCCURRED. ONE HANDPIECE RETURNED OVERHEATED DURING INVESTIGATION AND IS FILED UNDER REPORT #: 1017294-2008-00231. THE OTHER HANDPIECE RETURNED FOR EVAL DID NOT OVERHEAT DURING INVESTIGATION. THIS UNIT TESTED TO SPECIFICATION; AND THEREFORE, IS ONLY LISTED AS A CONCOMITANT DEVICE. THE MANUAL AND INSTRUCTION FOR USE (IFU) INFORM THE USER TO MONITOR THE DRILL AND BUR GUARD FOR OVERHEATING PRE-OPERATIVELY AS WELL AS DURING USE. IT IS KNOWN THAT OVERTIME BEARINGS WILL WEAR THROUGH USE AND CAN CAUSE A BURN INJURY TO THE PT/USER. TO TEST THE BUR GUARD, SPIN THE BUR GUARD ON THE BUR. IF THE BUR GUARD SPINS FREELY, THE BEARINGS ARE GOOD. OTHERWISE, THE BUR GUARD SHOULD NOT BE USED AND SHOULD BE SENT IN FOR REPAIR. IN ADDITION, PRIOR TO USE WITH THE BUR GUARD AND BUR LOCKED SECURELY FOR OVERHEATING. THE SERVICE INTERVAL FOR THIS BUR GUARD IS EVERY 6 MONTHS. THE CUSTOMER WILL BE CONTACTED WITH ADD'L INFO REGARDING THIS PRODUCT.