BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 2230959 · Received July 19, 2011

    Report

    Report Number
    1811755-2011-02615
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 25, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. DURING THE INVESTIGATION IT WAS FOUND THAT THE MAGNET HAD FALLEN OUT OF THE TRIGGER AND ATTACHED ITSELF TO THE E-BOX SENSOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING THE DEVICE RAN WITHOUT THE TRIGGER BEING PULLED. THERE WERE NO ADVERSE CONSEQUENCES 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