BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 ASEPTIC HOUSING ASSY

    MDR report key: 2455623 · Received February 1, 2012

    Report

    Report Number
    1811755-2012-00368
    Event Type
    Malfunction
    Date Received
    February 1, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 11, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A NON-CONFORMANCE WAS OPENED IN THE CAPA PROCESS TO ADDRESS THIS ISSUE. CONTINUED TESTING TO DETERMINE A ROOT CAUSE OF THE EVENT WILL BE PERFORMED AND TRACKED IN THIS NON-CONFORMANCE. THIS ISSUE WILL BE MONITORED AND REVIEWED IN ACCORDANCE TO THE CAPA PROCEDURES, AND IF ANY CORRECTIVE ACTIONS ARE REQUIRED THEY WILL BE CAPTURED AND INITIATED THROUGH THIS PROCESS. A F/U REPORT WILL BE SUBMITTED WHEN THE ROOT CAUSE HAS BEEN DETERMINED.

    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 PT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 6 ASEPTIC HOUSING ASSY KIJ STRYKER INSTRUMENTS KALAMAZOO 08267

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK