BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 ASEPTIC HOUSING ASSY

    MDR report key: 3100214 · Received May 8, 2013

    Report

    Report Number
    0001811755-2013-01060
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COMMENT WAS CONFIRMED. IT WAS FOUND DURING EVALUATION THAT THE DELRIN WAS STILL PRESENT IN THE BATTERY HOUSING BUT THAT IT HAD DEGRADED AND WAS NOT FUNCTIONING PROPERLY. BASED ON SIMILAR COMPLAINTS, POSSIBLE CAUSES INCLUDE WEAR AND TEAR OR MECHANICAL DAMAGE TO THE DELRIN BALL.

    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.

    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
    200661 SYSTEM 6 ASEPTIC HOUSING ASSY INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO 11032

    Patients

    Seq Age Sex Outcome Treatment
    1