BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 ASEPTIC HOUSING ASSY

    MDR report key: 1935628 · Received December 14, 2010

    Report

    Report Number
    1811755-2010-02020
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 26, 2010
    Report Date
    November 29, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR INVESTIGATION. IF ADDITIONAL INFO IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASEPTIC HOUSING OPENED DURING A PROCEDURE, EXPOSING THE SURGICAL SITE TO THE NON-STERILE BATTERY. THERE ARE NO ALLEGATIONS OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 6 ASEPTIC HOUSING ASSY INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO 09096

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK