BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 ASEPTIC HOUSING ASSY

    MDR report key: 2132297 · Received June 11, 2011

    Report

    Report Number
    1811755-2011-02143
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 8, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS CONFIRMED THAT THE DELRIN BALL WAS MISSING FROM THE LATCHING MECHANISM. THE ROOT CAUSE OF THE MISSING BALL IS UNKNOWN AT THIS TIME. THE QUALITY INVESTIGATION IS ONGOING; A FOLLOW UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE INSPECTING THE ASEPTIC BATTERY HOUSING, IT WAS DETERMINED THAT THE DELRIN BALL IN THE LOCKING MECHANISM OF THE HOUSING WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE ABSENCE OF THE DELRIN BALL COULD CAUSE THE HOUSING TO NOT LOCK COMPLETELY, LEADING TO EXPOSURE OF THE NON-STERILE BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 6 ASEPTIC HOUSING ASSY KIJ STRYKER INSTRUMENTS KALAMAZOO 09075

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK