BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERWIRE

    MDR report key: 856842 · Received May 4, 2007

    Report

    Report Number
    856842
    Event Type
    Malfunction
    Date Received
    May 4, 2007
    Date of Event
    April 30, 2007
    Report Date
    May 4, 2007
    Manufacturer
    ARTHREX ARTHROSCOPY INSTRUMENTS, INC.
    Product Code
    GAO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FIBERWIRE SUTURE FRAYING DURING SURGICAL PROCEDURE. IT HAS HAPPENED ON SEVERAL OCCASIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBERWIRE SUTURE GAO ARTHREX ARTHROSCOPY INSTRUMENTS, INC. * 02948

    Patients

    Seq Age Sex Outcome Treatment
    1 *