BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FF 360

    MDR report key: 3163125 · Received June 11, 2013

    Report

    Report Number
    1219602-2013-00126
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 15, 2013
    Manufacturer
    SMITH & NEPHEW
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE DEVICE WAS RETURNED FOR EVALUATION. ONLY THE DELIVERY UNIT WAS RETURNED AND THE DEVICE WAS RECEIVED WITHOUT SUTURE OR ANCHOR. THE INCIDENT REPORT CONFIRMS THAT THIS IS RELATED TO CAPA (B)(4), WHICH HAS BEEN OPENED TO TRACK THE ROOT CAUSE AND CORRECTIVE ACTIONS RELATED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    DURING A MENISCAL REPAIR, THE SURGEON WAS USING A FAST-FIX 360 CURVED FROM LOT 50444632. THE SURGEON INSERTED THE NEEDLE AND WAS ABLE TO SUCCESSFULLY SEAT THE FIRST T1 IMPLANT ON THE CAPSULAR SIDE. WHILE REMOVING THE INSERTER NEEDLE AND ATTEMPTING TO INSERT THE SECOND T2 IMPLANT, THE IMPLANT BECAME LOOSE FROM THE INSERTER AND FELL OFF INTO THE JOINT WITHOUT THE DEVICE BEING ACTUATED. T2 WAS SUBSEQUENTLY CUT FROM THE MENISCUS AND T1 WAS LEFT IN THE PATIENT UNSUPPORTED. A SECOND FAST-FIX 360 CURVED FROM LOT 50453311 WAS THEN USED. THE SURGEON INSERTED THE NEEDLE AND WAS ABLE TO SUCCESSFULLY SEAT THE FIRST T1 IMPLANT ON THE CAPSULAR SIDE. WHILE REMOVING THE INSERTER NEEDLE AND ATTEMPTING TO INSERT THE SECOND T2 IMPLANT, THE IMPLANT BECAME LOOSE FROM THE INSERTER AND FELL OFF INTO THE JOINT WITHOUT THE DEVICE BEING ACTUATED. T2 WAS SUBSEQUENTLY CUT FROM THE MENISCUS AND T1 WAS LEFT IN THE PATIENT UNSUPPORTED. A THIRD BACKUP DEVICE WAS ON HAND TO ULTIMATELY COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263407 FF 360 FAST-FIX 360 CURVED NDL DELIVERY SYS GAT SMITH & NEPHEW 50444632

    Patients

    Seq Age Sex Outcome Treatment
    1