BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 ASEPTIC HOUSING ASSY

    MDR report key: 1890619 · Received October 25, 2010

    Report

    Report Number
    1811755-2010-01483
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 27, 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 HAS NOT BEEN RETURNED TO THE ACCOUNT AS OF THE DATE OF THIS REPORT. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE DEVICE FROM THE ACCOUNT. THIS REPORT WILL BE UPDATED WHEN THE DEVICE IS RECEIVED AND AN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOUSINGS OPENED DURING A SURGERY EXPOSING THE NON-STERILE BATTERY TO THE STERILE SITE. ADD'L INFO HAS BEEN REQUESTED FROM THE ACCOUNT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK