BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTION HANDLE

    MDR report key: 1787775 · Received July 29, 2010

    Report

    Report Number
    2249697-2010-00939
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 6, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER LOTS OF DEVICES FOR THIS CAT # WERE ALSO LISTED IN THIS REPORT: LOT CRZK01, DEVICE MANUFACTURE DATE: 10/25/2005; LOT CRZA01, DEVICE MANUFACTURE DATE: 4/6/2005; LOT CRZH01, DEVICE MANUFACTURE DATE: 7/12/2005. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS IS THE SAME EVENT AS: MFR # 2249697-2010-00931, MFR # 2249697-2010-00932, MFR # 2249697-2010-00933, MFR # 2249697-2010-00934, MFR # 2249697-2010-00935, MFR # 2249697-2010-00936, MFR # 2249697-2010-00937, MFR # 2249697-2010-00938, MFR # 2249697-2010-00940, MFR # 2249697-2010-00941, MFR # 2249697-2010-00942, MFR # 2249697-2010-00943.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "ALL TRIATHLON PRODUCT LISTED ABOVE WITH GREEN HANDLES LEAKS AN OILY, FATTY KIND OF LIQUID AFTER STERILIZATION. THEY WERE THEN RESTERILIZED BY HAND. AFTER BEING HAND WASHED AND MACHINE WASHED THEY WERE STERILIZED AND REOPENED AND EXAMINED AND FOUND THE SAME RESULT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACTION HANDLE INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA CRZV01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other