BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL LONG STRAIGHT ATTACHMENT

    MDR report key: 1873612 · Received September 17, 2010

    Report

    Report Number
    1811755-2010-01205
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 31, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTACHMENT WAS RECEIVED AT THE MANUFACTURER FOR EVALUATION, AND THE REPORTED CONDITION OF THE DEVICE OVERHEATING WAS CONFIRMED. THE DEVICE WAS DISASSEMBLED, AND CORROSION AND DEBRIS WERE FOUND IN THE NOSE OF THE DEVICE. BASED ON THE INVESTIGATION DETAILS, THE FAILURE WAS MOST LIKELY CAUSED BY CORROSION BUILD UP IN THE ATTACHMENT DURING USE. THE FRONT OF THE ATTACHMENT HAS A GAP BETWEEN THE BUR PILOT AND THE OUTER HOUSING, WHICH HAS THE POTENTIAL TO ALLOW CORROSION AND DEBRIS TO ENTER THE ATTACHMENT. ONCE ENOUGH CORROSION BUILDS UP IN THE ATTACHMENT IT MAY CAUSE THE DEVICE TO NOT WORK PROPERLY OR CAN PHYSICALLY BIND UP THE ATTACHMENT. THE ATTACHMENT WAS SCRAPPED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATTACHMENT BEGAN OVERHEATING DURING A SURGICAL PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY USING A BACK-UP DEVICE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO DRILL LONG STRAIGHT ATTACHMENT SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC DZJ STRYKER INSTRUMENTS KALAMAZOO 09339

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK