BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER INSTRUMENTS

    MDR report key: 1033949 · Received April 24, 2008

    Report

    Report Number
    MW5006392
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 24, 2008
    Manufacturer
    STRYKER INSTRUMENT
    Product Code
    GFF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    WHILE USING A STRYKER CORE 3 SURGICAL DRILL, THE PLASTIC BUR SHIELD PROTECTING THE BUR SHAFT AND ROTATING TIP BOND, FUSED AND MELTED TO THE ROTATING TIP. THIS OCCURRED WITHIN A MILLISECOND AND RESULTED IN A SEVERE ABRASION/BURN TO THE PT'S LIP. THIS IS THE 3RD TIME I HAVE HAD A SIMILAR PROBLEM WITH THIS BUR SHIELD DESIGN AND HAVE CONTACTED THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER INSTRUMENTS BUR SHIELD GFF STRYKER INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other