BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRIVER SHAFT

    MDR report key: 2110163 · Received May 19, 2011

    Report

    Report Number
    2249697-2011-00748
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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, "SCREWDRIVER TIP FAILED DURING SCREW INSERTION. TIP REMAINED LOGGED IN TRIDENT SCREW IN THE PATIENT. SCREW WAS FULLY SEATED AND SURGEON ELECTED TO LEAVE THE SCREWDRIVER TIP IN PLACE AND INSERTED POLYETHYLENE LINER."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention