BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 620530 · Received June 29, 2005

    Report

    Report Number
    620530
    Event Type
    Other
    Date Received
    June 29, 2005
    Date of Event
    June 24, 2005
    Report Date
    June 29, 2005
    Manufacturer
    SYNTHES USA, INC.
    Product Code
    HXI
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS IN THE OR FOR A FUSION OF THE FIRST METATARSOPHALANGEAL JOINT. DURING THE PROCEDURE, THE GUIDEWIRE TIP BROKE OFF IN THE PATIENT'S BONE. PLACEMENT WAS CONFIRMED ON X-RAY. THE TIP WAS LEFT IN PLACE BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ORTHOPEDIC GUIDEWIRE HXI SYNTHES USA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR