BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 1854441 · Received September 30, 2010

    Report

    Report Number
    1811755-2010-01292
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 3, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE HAS BEEN RECEIVED AT THE MANUFACTURER FOR INVESTIGATION. AN EVALUATION WAS CONDUCTED AND THE COMPLAINT WAS CONFIRMED. ACCORDING TO THE INVESTIGATION DETAILS, THE FETS WERE DAMAGED AND THE EBOX FAILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE DID NOT COME TO A STOP IMMEDIATELY AFTER THE TRIGGER WAS RELEASED, BUT COASTED TO A STOP. THIS WAS FOUND DURING TESTING OF THE EQUIPMENT, THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDLESS DRIVER 3 INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK