BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX/IMPLANTS

    MDR report key: 2101212 · Received May 24, 2011

    Report

    Report Number
    1219602-2011-00084
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 26, 2011
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED WITHOUT THE SUTURE/IMPLANT ASSEMBLY. IT WAS NOT POSSIBLE TO MOVE THE GOLD TRIGGER TO ADVANCE THE PUSHROD. THE DEVICE WAS DISASSEMBLED AND IT WAS NOTED UPON REMOVAL OF THE BLUE STRAW THAT THE NEEDLE HAD A SHARP KINK IN IT PROHIBITING MOVEMENT OF THE PUSHROD. THE KINK WAS NOT PRESENT DURING ASSEMBLY AS IT WOULD HAVE HAMPERED PLACEMENT OF THE BLUE STRAW. IT APPEARS THAT FORCES APPLIED DURING PLACEMENT OF T1, DEFORMED THE NEEDLE. NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE CAN BE ESTABLISHED. (B)(4).

    Description of Event or Problem · 1

    AFTER DEPLOYING T1 THE SURGEON TRIED TO ADVANCE THE TRIGGER TO SET T2 BUT IT WOULD STIFF AND WOULD NOT MOVE AT ALL. THE DEPLOYED T1 COULD NOT BE RETRIEVED AND WAS LEFT INSIDE THE PATIENT. THE SURGEON CUT THE SUTURE AND GAVE UP ON THE DEVICE. PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-FIX/IMPLANTS ULTRA FAST-FIX ASSEMBLY - CURVED GAT SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE 72201491 50358100

    Patients

    Seq Age Sex Outcome Treatment
    1