BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR CORE U DRIVER

    MDR report key: 1556712 · Received November 13, 2009

    Report

    Report Number
    1811755-2009-00753
    Event Type
    Malfunction
    Date Received
    November 13, 2009
    Date of Event
    October 13, 2009
    Report Date
    October 13, 2009
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRIVER HAS BEEN RECEIVED AT THE MFR, AND A QUALITY EVAL WILL BE CONDUCTED. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE CONTINUED TO RUN ON ITS OWN DURING AN ORTHOPAEDIC PROCEDURE. THERE HAS BEEN 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 REPAIR CORE U DRIVER SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK