BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 3843436 · Received June 2, 2014

    Report

    Report Number
    0001811755-2014-02012
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT STICKING TRIGGER AND NOISE WAS CONFIRMED BY THE REPAIR TECHNICIAN THROUGH FUNCTIONAL EVALUATION, DISASSEMBLY AND VISUAL INSPECTION. THE TRIGGER WAS DETERMINED TO BE DEFORMED AND THE MOTOR BEARING WAS DAMAGED. THIS MAY CAUSE THE DESCRIBED EVENTS. THE AFFECTED TRIGGER ASSEMBLY AND MOTOR BEARING WERE REPLACED. COMPONENTS NOT ASSOCIATED WITH THE COMPLAINT WERE REPLACED AS PART OF PREVENTIVE MAINTENANCE AND THE HANDPIECE RETURNED TO THE ACCOUNT AFTER PASSING FINAL INSPECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FORWARD TRIGGER IN THE CORDLESS DRIVER IS STICKING AND IT CAUSED RUN ON DURING ROUTINE MAINTENANCE. NO ASSOCIATED PROCEDURE, NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322122 CORDLESS DRIVER 3 ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1