BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 ASEPTIC HOUSING ASSY

    MDR report key: 3935236 · Received July 15, 2014

    Report

    Report Number
    0001811755-2014-02521
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 19, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT, DELRIN BALL IS MISSING, WAS CONFIRMED. THE TECHNICIAN OBSERVED THAT THE DELRIN BALL WAS MISSING AND THE HINGE WAS BROKEN ON ONE SIDE OF THE HOUSING DUE TO IMPROPER STERILIZATION. A CHEMICAL ATTACK CAN OCCUR ON THE HOUSING AS A RESULT OF IMPROPER CLEANING PRACTICES, INCLUDING IMPROPER RINSING, USE OF IMPROPER CONCENTRATION OF A BASIC DISINFECTANT. DEVICE WAS PLACED IN PARTS RETENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASEPTIC BATTERY HOUSINGS HAVE DELRIN BALL MISSING FROM THE LATCH MECHANISM WHICH CAN LEAD TO POTENTIAL FOR HOUSING TO OPEN AND EXPOSE NON STERILE BATTERY TO THE SURGICAL SITE. IT WAS NOTICED DURING INSPECTION, 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
    414226 SYSTEM 6 ASEPTIC HOUSING ASSY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO 12044

    Patients

    Seq Age Sex Outcome Treatment
    1