BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA FF

    MDR report key: 2990323 · Received March 5, 2013

    Report

    Report Number
    1219602-2013-00058
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    January 8, 2013
    Report Date
    February 6, 2013
    Manufacturer
    MANSFIELD MANUFACTURING SITE
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION CONFIRMED THAT T1 WAS NOT RETURNED, AS IT WAS REPORTED THAT IT WAS LEFT IN THE PATIENT. THE SUTURE WAS OBSERVED TO BE CUT RIGHT AT THE BOTTOM OF THE T1 LOCATION, THIS OBSERVATION INDICATES THAT THE SUTURE MAY HAVE BEEN CUT BY THE NEEDLE AS THE SURGEON STATED HE/SHE TURNED THE NEEDLE 90 DEGREES AND PULLED IT OUT UPON IMPLANTING T1. FUNCTIONAL TESTING WAS PERFORMED AND THE ACTUATOR WAS FULLY ADVANCED OVER THE DIMPLE AND T2 DEPLOYED WITHOUT ISSUE INTO A RUBBER MENISCUS, FUNCTIONING AS INTENDED. BASED ON THESE OBSERVATIONS, NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE CAN BE ESTABLISHED. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    WHEN THE SURGEON INSERTED THE ULTRA FAST-FIX INTO THE MENISCUS AND TURNED IT 90 DEGREES AND PULLED OUT TO DEPLOY THE T1 IMPLANT, THEY FOUND THAT THE SUTURE BROKE AWAY FROM THE T1 AND THE KNOT SEEMED TO BE UNTIED. ACCORDING THE REPORT FROM THE SURGEON, THEY USED THE DEVICE AS USUAL AND DID NOT PULL WITH EXCESSIVE FORCE. THE T1 REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93839 ULTRA FF ULTRA FAST-FIX ASSEMBLY -CVD GAT MANSFIELD MANUFACTURING SITE 72201491 50401406

    Patients

    Seq Age Sex Outcome Treatment
    1