BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 3830560 · Received May 23, 2014

    Report

    Report Number
    0001811755-2014-01890
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 30, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE WAS CONFIRMED THROUGH FUNCTIONAL TESTING, DISASSEMBLY AND VISUAL INSPECTION. CORROSION WAS FOUND AND IT WAS DETERMINED THAT THE E-BOX REQUIRED REPLACEMENT AS IT CAUSED THE MOTOR NOT TO FUNCTION CORRECTLY DUE TO LEAKING. THE AFFECTED E BOX, BEARING AND GEARHEAD WERE REPLACED. A BAD E-BOX WILL CAUSE THE MOTOR TO FAIL THE HI-POT TEST AND LEAK. THE DEVICE PASSED ALL FINAL INSPECTION ACTIVITIES PRIOR TO RETURN TO THE CUSTOMER AFTER REPAIR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE HAS A OILY SUBSTANCE ON THE BOTTOM CAP. IT WAS NOTICED AFTER THE PROCEDURE WAS COMPLETED AT THE USER FACILITY. 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
    308336 CORDLESS DRIVER 3 ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1