BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA FAST-FIX ASSEMBLY - CURVED

    MDR report key: 7645781 · Received June 28, 2018

    Report

    Report Number
    1219602-2018-00839
    Event Type
    Malfunction
    Date Received
    June 28, 2018
    Date of Event
    June 23, 2018
    Report Date
    September 4, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    03596010597205
    PMA / PMN Number
    K072322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 72201491 ULTRA FAST-FIX CURVED NEEDLE DELIVERY SYSTEM RECEIVED. THE COMPLAINT STATED: T1 PIERCED MENISCUS AND WAS BACKOUT, T2 FELL OFF. PLANER TOOL WAS USED TO CLEAN AND THEN OTHER DEVICE WAS OPENED, BUT SAME MATTER APPEARED." THE BLUE SPLIT CANNULA WAS RETURNED COVERING THE NEEDLE. THE WHITE DEPTH LIMITER IS ATTACHED. IT WAS TRIMMED TOO SHORT FOR THE APPLICATION. IT IS TRIMMED BACK BEYOND THE TIP OF THE BLUE INNER SHEATH. T1, T2 AND SUTURE WERE NOT RETURNED. THE NEEDLE IS EXTREMELY BOWED, BENT TOWARD THE RIGHT AND TWISTED AT THE DISTAL TIP. TWISTING OR BENDING OF THE NEEDLE TRACK MAY ENCOURAGE RELEASE OF T WHEN NOT INTENDED. TWISTING OR BENDING OF THE NEEDLE TRACK CAN INTERFERE WITH ADVANCEMENT AND RELEASE OF T'S. THE CONDITION IS CONSISTENT WITH DIFFICULTY IN REACHING DESIRED LOCATION. THE MANUAL ADVANCEMENT LEVER WAS POSITIONED FULLY FORWARD. IFU INSTRUCTS TO MANUALLY POSITION T1 FOR STRIPPING OFF AND THEN MANUALLY PUSH THE LEVER FULLY TO THEN POSITION T2 FOR STRIPPING OFF. ADVANCING THE LEVER FULLY IN ONE MOTION MAY PREMATURELY RELEASE T2. NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE WAS CONFIRMED. COUNTRY WAS LEFT BLANK, SHOULD BE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MENINGEORRHAPHY SURGERY, WHEN T1 PIERCED MENISCUS AND WAS BACK OUT, T2 FELL OFF. PLANER TOOL WAS USED TO CLEAN AND THEN OTHER DEVICE WAS OPENED, BUT SAME MATTER APPEARED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO MAJOR DELAY OR PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486893 ULTRA FAST-FIX ASSEMBLY - CURVED SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 72201491 50687129 03596010597205

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR