BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 ASEPTIC HOUSING ASSY

    MDR report key: 1935582 · Received December 14, 2010

    Report

    Report Number
    1811755-2010-02018
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 24, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR INVESTIGATION. REQUESTS HAVE BEEN MADE FOR ADDITIONAL INFO. IF THE DEVICE OR ADDITIONAL INFO ARE REC'D, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY HOUSING OPENED DURING THE PROCEDURE, EXPOSING THE STERILE FIELD TO THE NON-STERILE BATTERY. IT IS UNK IF THE PT REC'D ANY ADDITIONAL TREATMENT DUE TO 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK