BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 STRAIGHT NDL DLVRY SYS

    MDR report key: 2955631 · Received February 11, 2013

    Report

    Report Number
    1219602-2013-00036
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 16, 2013
    Manufacturer
    SMITH & NEPHEW INC MANSFIELD MANUFACTURING SITE
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO DEVICES WERE RETURNED WITH JUST THE DELIVERY PORTION OF THE DEVICE. NO IMPLANT OR SUTURE WERE PROVIDED. BOTH OF THE DELIVERY DEVICES WERE FUNCTIONALLY TESTED AND FOUND TO ACTUATE AS INTENDED WITH THE ACTUATOR MOVING TO ITS PROPER POSITIONS. REVIEW OF THE DEVICE HISTORY RECORDS WERE PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. THERE WERE NO INTERNAL PROCESSING ISSUES, WHICH COULD HAVE CONTRIBUTED TO THE NATURE OF THE COMPLAINT. DUE TO THIS FACT WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE USER TO EXPERIENCE THE REPORTED INCIDENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING MENISCUS REPAIR, ON THE FIRST FAST-FIX 360 IT WENT THROUGH THE MENISCUS FIRING OK, BUT WOULD NOT RELEASE THE SECOND THROUGH, THE SECOND FAST FIX WOULD NOT FIRE AT ALL. ADDITIONAL INFORMATION CONFIRMED "THE SECOND T BAR WOULD NOT DEPLOY PROPERLY ON BOTH OCCASIONS. SURGEON HAD TO CUT THE SUTURE TO FREE THE REST OF THE DEVICE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58222 FAST-FIX 360 STRAIGHT NDL DLVRY SYS FAST-FIX 360 STRAIGHT NDL DLVRY SYS GAT SMITH & NEPHEW INC MANSFIELD MANUFACTURING SITE 50423201

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR