BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA FAST-FIX AB ASSEMBLY - CURVED

    MDR report key: 2914475 · Received January 14, 2013

    Report

    Report Number
    1219602-2013-00019
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    SMITH & NEPHEW, INC. MANSFIELD MANUFACTURING SITE
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IMPLANT WOULD NOT DEPLOY, OPENED ANOTHER AND CONTINUED. ADDITIONAL INFORMATION CONFIRMED THAT T1 WAS DEPLOYED WITHOUT ISSUE WHEN THE SURGEON WENT TO DEPLOY T2 IT WOULD NOT STRIP OFF THE NEEDLE. T1 WAS LEFT UNSUPPORTED BEHIND THE CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20173 ULTRA FAST-FIX AB ASSEMBLY - CURVED ULTRA FAST-FIX AB ASSEMBLY - CURVED GAT SMITH & NEPHEW, INC. MANSFIELD MANUFACTURING SITE 50439622

    Patients

    Seq Age Sex Outcome Treatment
    1