BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FF 360

    MDR report key: 3090648 · Received May 2, 2013

    Report

    Report Number
    1219602-2013-00096
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MANSFIELD MANUFACTURING SITE
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE ANCHOR WITH SUTURE WAS RETURNED FOR EVALUATION. THE DELIVERY DEVICE WAS NOT RETURNED. VISUAL INSPECTION OF THE ANCHOR IDENTIFIED IT AS T2. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. NO ROOT CAUSE RELATED TO THE MANUFACTURING OF THE DEVICE CAN BE ESTABLISHED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING KNEE ARTHROSCOPY WITH MENISCAL REPAIR THE FASTFIX SYSTEM DID NOT DEPLOY. THERE WAS MINIMAL DELAY TO RETRIEVE A NEW DEVICE AND REMOVE THE MALFUNCTIONING ONE. ONLY T2 WAS RETURNED FOR EVALUATION. CUSTOMER CONTACT ALEX, WAS UNAWARE IF T1 REMAINS IN THE PATIENT OR WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192957 FF 360 FAST-FIX 360 CURVED NDL DEL SYS GAT MANSFIELD MANUFACTURING SITE 72202468 50449361

    Patients

    Seq Age Sex Outcome Treatment
    1