BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE UNIVERSAL DRIVER

    MDR report key: 1983972 · Received January 11, 2011

    Report

    Report Number
    1811755-2011-00074
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRIVER WAS RECEIVED AT THE MANUFACTURER FOR EVALUATION, AND THE REPORTED CONDITION OF THE DEVICE RUNNING AFTER THE TRIGGER IS RELEASED WAS DUPLICATED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS CORROSION IN THE MOTOR AND POTTED TRIGGER ASSEMBLY, AS WELL AS, PROBLEMS WITH THE DRIVESHAFT AND BEARINGS. THOSE PARTS WERE REPLACED ALONG WITH OTHER COMPONENTS. SERVICE REPAIRED AND RETURNED THE DEVICE TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRIVER CONTINUED TO RUN ON ITS OWN DURING A SURGICAL PROCEDURE. THE CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE UNIVERSAL DRIVER SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK