BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3212303 · Received July 1, 2013

    Report

    Report Number
    3212303
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    May 13, 2013
    Report Date
    July 1, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO IMPLANT ANCHOR THE SUTURE BECAME TWISTED AROUND ANCHOR. THE SUTURE HAD TO BE CUT WAY FROM THE ANCHOR MAKING THE ANCHOR UNUSABLE. THERE WAS NO HARM TO THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?RIGHT SHOULDER ARTHROSCOPY WITH ROTATOR CUFF REPAIR.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297692 * SUTURE ANCHOR GAT ARTHREX, INC. * 598866

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR