BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRE-OWNED U DRIVER

    MDR report key: 1617622 · Received February 11, 2010

    Report

    Report Number
    1811755-2010-00106
    Event Type
    Malfunction
    Date Received
    February 11, 2010
    Date of Event
    January 13, 2010
    Report Date
    January 13, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MFR FOR EVAL, AND THE REPORTED CONDITION OF THE DEVICE CONTINUING TO RUN ON ITS OWN WAS CONFIRMED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE FOR THE OVERHEATING WAS PROBLEMS WITH THE MOTOR, ROTOR, AND GEARTRAIN, WHICH WERE EACH REPLACED ALONG WITH OTHER COMPONENTS AS PART OF PREVENTIVE MAINTENANCE. SERVICE REPAIRED AND RETURNED THE DEVICE TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE CONTINUED TO RUN ON ITS OWN DURING A LUXATING PATELLA PROCEDURE. THERE WAS NO REPORTED PT OR USER INJURY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK