BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 2 HANDPIECE

    MDR report key: 2200932 · Received July 1, 2011

    Report

    Report Number
    1811755-2011-02390
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR AND UPON EVAL THE COMPLAINT COULD NOT BE CONFIRMED. THE ASIC MOTOR CONTROL AND ASSEMBLY NEEDED TO BE REPLACED IN ADDITION TO SEVERAL OTHER COMPONENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE RAN ON ITS OWN DURING A SURGICAL PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES. A BACK-UP DEVICE WAS USED AND THERE WAS NO DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDLESS DRIVER 2 HANDPIECE HRX STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK