BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 REVERSED CURVE NDL DELIV

    MDR report key: 2840787 · Received November 20, 2012

    Report

    Report Number
    1219602-2012-00315
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ACL MENISCAL REPAIR THE SURGEON WAS USING SEVERAL FAST-FIX 360 DEVICES TO COMPLETE THE PROCEDURE. A FAST-FIX 360, CURVED WAS INSERTED INTO THE MENISCUS AND T1 WAS DEPLOYED, UPON PULLING BACK AND PUSHING THE INSERTER NEEDLE FORWARD TO DEPLOY T2 THE INNER PLUG NEVER CAME BACK AND CONSEQUENTLY T2 DID NOT DEPLOY. T2 CAME OFF AND WAS PULLED OUT AND THE SUTURE WAS CUT OFF. A SECOND FASTFIX 360, CURVED WAS THEN USED AND AGAIN T1 WAS DEPLOYED, HOWEVER, UPON PULLING BACK THE INSERTED NEEDLE AGAIN WOULD NOT DEPLOY T2. T2 CLICKED FORWARD AND WHEN PULLED BACK WOULD NOT DEPLOY, TRIED 2 MORE TIMES AND DID NOT WORK. EVENTUALLY T2 CAME OFF THE NEEDLE, T2 WAS CUT OUT OF THE PATIENT AND THE SUTURE WAS CUT DOWN. A 72202467 FAST-FIX 360, STRAIGHT WAS INSERTED IN THE MENISCUS AND T1 WAS DEPLOYED, THE NEEDLE WAS PULLED BACK AGAIN TO DEPLOY T2 , THE AUDIBLE CLICK WAS HEARD, HOWEVER, WHEN PULLED BACK T2 DID NOT DEPLOY. EVENTUALLY T2 CAME OFF THE NEEDLE, THE IMPLANT WAS REMOVED AND THE SUTURE CUT DOWN. A 72202469 FAST-FIX 360, STRAIGHT WAS INSERTED IN THE MENISCUS AND T1 WAS DEPLOYED, THE NEEDLE WAS PULLED BACK AGAIN TO DEPLOY T2 , THE AUDIBLE CLICK WAS HEARD, HOWEVER, WHEN PULLED BACK T2 DID NOT DEPLOY. EVENTUALLY T2 CAME OFF THE NEEDLE, THE IMPLANT WAS REMOVED AND THE SUTURE CUT DOWN. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. SALES REP CONFIRMED THE FOLLOWING ADDITIONAL INFORMATION, "FOR ALL FOUR IMPLANTS, T1 REMAINS IN THE PATIENT FOR EACH, ALL T2S WERE REMOVED. THE TOTAL TIME DELAY WAS 20-25 MINUTES, 5 MINUTES PER DEFECTIVE DEVICE. THE SURGEON WAS ABLE TO SUCCESSFULLY IMPLANT 6 ADDITIONAL FAST-FIX 360 DEVICES; NO OTHER METHOD OR PRODUCT WAS USED. THERE DID NOT APPEAR TO BE ANY VISUAL DAMAGE TO THE MENISCUS AS A RESULT OF THE REPEATED ISSUE WITH THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-FIX 360 REVERSED CURVE NDL DELIV FAST-FIX 360 REVERSED CURVE NDL DELIV GAT SMITH & NEPHEW MANSFIELD MANUFACTURING SITE 72202469 50401010

    Patients

    Seq Age Sex Outcome Treatment
    1