BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINOS MEDIUM BUR GUARD

    MDR report key: 1001068 · Received February 14, 2008

    Report

    Report Number
    1017294-2008-00108
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Report Date
    January 16, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    HTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THE BUR GUARD FOR EVALUATION AND CONFIRMED OVERHEATING RELATED TO BEARING ASSEMBLY FAILURE. A REVIEW OF REPAIR HISTORY RECORDS SHOW THAT THIS BUR GUARD WAS LAST REPAIRED IN 2005. THE INSTRUCTION MANUAL INFORMS THE USER TO INSPECT AND OPERATE THIS DEVICE FOR PROPER FUNCTION PRIOR TO USE. THE FOLLOWING WARNING IS PROVIDED IN THE MANUAL: DO NOT USE AIR DRILL WITHOUT THE PROPER BUR GUARD. ALSO, BE SURE THE ATTACHMENT IS PROPERLY LUBRICATED AND THE BEARING IS FUNCTIONING. FROZEN BEARINGS WILL CAUSE HEAT BUILD-UP AND POSSIBLE BURNS. THE CUSTOMER WILL BE CONTACTED WITH ADDITIONAL INFO REGARDING THIS DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE OF THIS BUR GUARD IN ORAL SURGERY, IT STARTED TO SMOKE AND BECAME HOT TO THE TOUCH. THE SURGEON REPLACED THE HANDPIECE AND BUR GUARD WITH AN ALTERNATE AND COMPLETED THE PROCEDURE WITHOUT INJURY OR SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINOS MEDIUM BUR GUARD BUR GUARD HTT CONMED LINVATEC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NK NK