BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 2230960 · Received July 19, 2011

    Report

    Report Number
    1811755-2011-02616
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE STOPPED WORKING DURING A SURGICAL PROCEDURE. THIS RESULTED IN A DELAY OF ONE AND A HALF HOURS. THE PROCEDURE WAS COMPLETED MANUALLY USING THE DRILL BIT AND NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDLESS DRIVER 3 HRX STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK