BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR CORDLESS DRIVER 3

    MDR report key: 2042807 · Received March 30, 2011

    Report

    Report Number
    1811755-2011-01019
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    July 2, 2010
    Report Date
    July 2, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GET
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY THE MANUFACTURER FOR EVALUATION AND REPAIR. ACCORDING TO THE INVESTIGATION DETAILS, THE COMPLAINT WAS CONFIRMED. THE TECHNICIAN DETERMINED THAT THE STRAIGHT PIN WAS GOUGING AND DEFORMING THE TRIGGER SHAFT, CAUSING THE TRIGGER TO STICK. THE DEVICE WAS REPAIRED IN THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE DEVICE STUCK IN THE FORWARD POSITION AND RAN ON ITS OWN DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT/USER INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY USING A BACK-UP DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK