BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 ASEPTIC HOUSING ASSY

    MDR report key: 3234084 · Received July 18, 2013

    Report

    Report Number
    0001811755-2013-01692
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT, OPENED DURING SURGERY, WAS DUPLICATED; IT WAS CONFIRMED THE DELRIN BALL DETENT WAS MISSING DURING VISUAL INSPECTION OF THE DEVICE. A MISSING DELRIN BALL MAY ALLOW THE LID OF THE HOUSING TO OPEN UNINTENTIONALLY, WHICH IS A PROBABLE CAUSE OF THE REPORTED EVENT. THE DEVICE WAS DISCARDED BY THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT THE EVALUATION HAS NOT YET BEGUN. ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETE. FAILURE ANALYSIS IS ONGOING; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE RESULTS ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASEPTIC BATTERY HOUSING OPENED UNEXPECTEDLY DURING A PROCEDURE. THERE WAS NO ALLEGATION OF ADVERSE CONSEQUENCES OR SURGICAL DELAY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASEPTIC BATTERY HOUSING OPENED UNEXPECTEDLY DURING A PROCEDURE. THERE WAS NO ALLEGATION OF ADVERSE CONSEQUENCES OR SURGICAL DELAY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335179 SYSTEM 6 ASEPTIC HOUSING ASSY INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO 12326

    Patients

    Seq Age Sex Outcome Treatment
    1