BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER

    MDR report key: 3040070 · Received April 1, 2013

    Report

    Report Number
    MW5029617
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 1, 2013
    Manufacturer
    STRYKER
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PLACEMENT OF SUTURE ANCHOR USING NANOTACK DRILL BIT 1.4 MM THE DRILL STOPPED. THE BATTERY WAS EXCHANGED IN SITU AND UPON RE-STARTING THE DRILL A MARKED INCREASE IN TORQUE WAS FELT AND THE DRILL BIT SNAPPED OFF IN THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132622 CORDLESS DRIVER DRILL BIT HTW STRYKER 4200
    132665 NANOTACK DRILL BIT DRILL BIT HTW PIVOT MEDICAL 1.4MM 13030501

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other