BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALL SURGICAL BUR GUARD

    MDR report key: 1062672 · Received June 16, 2008

    Report

    Report Number
    1017294-2008-00232
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 16, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    DZI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS BUR GUARD FOR EVAL AND FOUND BEARING BROKEN AND THE O-RING MISSING. IN ADDITION, THIS UNIT IS OVERDUE FOR PREVENTATIVE MAINTENANCE; CONMED LINVATEC REPAIR RECORDS SHOW NO REPAIR HISTORY SINCE 02/2000. 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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALL SURGICAL BUR GUARD BUR GUARD DZI CONMED LINVATEC NA FEB00

    Patients

    Seq Age Sex Outcome Treatment
    1 NK SUGAIRTOME TWO HANDPIECE CATALOG#: 00505800100