BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRIVER SHAFT

    MDR report key: 1890697 · Received November 1, 2010

    Report

    Report Number
    2249697-2010-01436
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    STRYKER ORTHPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "WHEN THE SURGEON WAS USING TO INSERT A SCREW, THE TIP OF THE UNIVERSAL DRIVER SHAFT WAS BROKEN. HE COULD NOT REMOVE THE FRAGMENT FROM THE SCREW HEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL DRIVER SHAFT INSTRUMENT LXH STRYKER ORTHPAEDICS MAHWAH NA F5A9383

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention