BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEX DRIVER/LXH

    MDR report key: 1661763 · Received April 16, 2010

    Report

    Report Number
    1020279-2010-00106
    Event Type
    Injury
    Date Received
    April 16, 2010
    Report Date
    April 16, 2010
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGERY TIME WAS EXTENDED BY THIRTY MINUTES DUE TO A BROKEN HEXDRIVER TIP. THE TIP WAS BROKEN, THEREFORE, IT COULD NOT CAPTURE THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEX DRIVER/LXH LXH SMITH & NEPHEW, INC. 478685

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization