BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 ASEPTIC HOUSING ASSY

    MDR report key: 3965028 · Received July 29, 2014

    Report

    Report Number
    0001811755-2014-02701
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    September 16, 2013
    Report Date
    July 2, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COMPLAINT, HOUSING OPENED, WAS DUPLICATED. THROUGH VISUAL INSPECTION, THE TECHNICIAN CONFIRMED THAT THE DELRIN BALL WAS MISSING. BASED ON SIMILAR COMPLAINTS, POSSIBLE CAUSES OF A MISSING DELRIN BALL INCLUDE WEAR AND TEAR, MECHANICAL DAMAGE TO THE DELRIN BALL THAT CAN CAUSE IT TO SHATTER, OR DEGRADATION OF THE DELRIN BALL DUE TO EXTENDED AUTOCLAVING. DEVICE IS PLACED IN PARTS RETENTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM 6 ASEPTIC HOUSINGS WERE OPENING UP ON SEVERAL OCCASIONS. AFTER RETURN TO THE MANUFACTURER FACILITY, IT WAS FOUND THAT THE DELRIN BALL IS MISSING FROM THE LATCH MECHANISMS WHICH CAN CAUSE THE HOUSINGS TO OPEN UP AND EXPOSE THE NON STERILE BATTERY TO THE SURGICAL SITE. THERE WAS NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440832 SYSTEM 6 ASEPTIC HOUSING ASSY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO 12192

    Patients

    Seq Age Sex Outcome Treatment
    1