BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 ASEPTIC HOUSING ASSY

    MDR report key: 3081104 · Received April 26, 2013

    Report

    Report Number
    0001811755-2013-00935
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 4, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS FOUND DURING EVALUATION THAT THE DELRIN WAS MISSING FROM THE BATTERY HOUSING. BASED ON SIMILAR COMPLAINTS, POSSIBLE CAUSES INCLUDE WEAR AND TEAR OR MECHANICAL DAMAGE TO THE DELRIN BALL THAT CAN CAUSE IT TO SHATTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DELRIN BALL IN THE LOCKING MECHANISM OF THE ASEPTIC BATTERY HOUSING WAS MISSING. NOTHING FELL INTO A SURGICAL SITE, AS THIS WAS DETERMINED WHILE INSPECTING THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183012 SYSTEM 6 ASEPTIC HOUSING ASSY INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO 11342

    Patients

    Seq Age Sex Outcome Treatment
    1