BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-HANDLE DRIVER

    MDR report key: 1951302 · Received December 14, 2010

    Report

    Report Number
    2249697-2010-01723
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS IS THE SAME EVENT AS: MFR# 2249697-2010-01721, MFR# 2249697-2010-01722, MFR# 2249697-2010-01724, MFR # 2249697-2010-01725, MFR# 2249697-2010-01726, MFR # 2249697-2010-01727, MFR # 2249697-2010-01728.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING THE SETUP FOR A TOTAL KNEE REPLACEMENT A SET OF TRIATHLON MISCELLANEOUS WERE OPENED AND UPON LIFTING THE LID OF THE TRAY, IT WAS NOTICED THAT ALL OF THE RUBBERIZED GREEN HANDLES HAD A SHINY FILM COATING THEM. THE SET UP WAS BROKEN DOWN AND THE INSTRUMENTS WERE RUN THROUGH THE WASHER STERILIZER AND THEN REPROCESSED IN THE AUTO CLAVE, AND THE SAME FILM WAS COATING THE HANDLES. THE CASE WAS CANCELLED AND RESCHEDULED FOR FRIDAY (B)(6)-2010. RETURNED THE SET TO THE OFFICE AND WILL REPLACE THE SET WITH ANOTHER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-HANDLE DRIVER INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA N3N26

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other