BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-HANDLE DRIVER

    MDR report key: 3953672 · Received July 23, 2014

    Report

    Report Number
    0002249697-2014-02849
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 1, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING SET UP PHASE PRIOR TO SURGERY THE T HANDLE DRIVER (6541-4-800) WAS HANDLED AND LIQUID (SUBSTANCE) EXCRETED OUT OF THE ATTACHMENT PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430437 T-HANDLE DRIVER INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other