BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 3260235 · Received August 1, 2013

    Report

    Report Number
    1219602-2013-00171
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 3, 2013
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY:ONE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION CONFIRMED THAT ONLY THE DELIVERY UNIT WAS RETURNED, NO T¿S OR SUTURE WERE RETURNED FOR EVALUATION AS THE REPORT INDICATED THE T¿S WERE LEFT BEHIND THE CAPSULE. FUNCTIONAL TESTING WAS PERFORMED AND THE ACTUATOR CYCLED AS INTENDED AND INDEXED TO THE CORRECT POSITIONS. DUE TO THE CONDITION OF THE RETURNED DEVICE NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE CAN BE ESTABLISHED. A 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. (B)(4).

    Description of Event or Problem · 1

    DURING A MENISCAL REPAIR USING A FAST-FIX 360 CURVED NDL DELIVERY SYS, IT WAS REPORTED THAT THE TWO IMPLANTS WERE ACTIVATED AT THE SAME TIME INTO THE MENISCUS. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS. ADDITIONAL INFORMATION CONFIRMED BOTH T¿S WERE FIRED AND STAYED IN THE JOINT BEHIND THE CAPSULE , PROCEDURE FINISHED WITH ANOTHER FASTFIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359900 FAST-FIX 360 CURVED NDL DELIVERY SYS FAST-FIX 360 CURVED NDL DELIVERY SYS GAT SMITH & NEPHEW MANSFIELD MANUFACTURING SITE 50460513

    Patients

    Seq Age Sex Outcome Treatment
    1