BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT

    MDR report key: 4905582 · Received July 10, 2015

    Report

    Report Number
    1219602-2015-00282
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 12, 2015
    Report Date
    June 12, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K072322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS MARKED AS AVAILABLE FOR EVALUATION; ALTHOUGH ANTICIPATED, THE DEVICE HAS NOT YET BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    DURING A MENISCAL REPAIR, IT WAS REPORTED THAT THE T2 ANCHOR DID NOT DEPLOY. ANOTHER FAST-FIX DEVICE WAS USED TO COMPLETE THE REPAIR. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449884 ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT SUTURE, NONABSORBABLE, SYNTHETIC, PE GAT SMITH & NEPHEW, INC. 50491168

    Patients

    Seq Age Sex Outcome Treatment
    1