BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA ULTRA FAST-FIX ASSEMBLY - CURVED

    MDR report key: 4910506 · Received July 13, 2015

    Report

    Report Number
    1219602-2015-00314
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    January 6, 2015
    Report Date
    July 13, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K072322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE DEVICE WAS RETURNED FOR EVALUATION. THE INTRODUCER NEEDLE, SUTURES AND ANCHORS WERE RETURNED HOWEVER T1 IS NO LONGER ON THE NEEDLE. THE DEVICE WAS VISUALLY EVALUATED AND ACTUATOR KNOB IN THE NON-DEPLOYMENT POSITION. THE DEVICE WAS FUNCTIONALLY TESTED; THE DEPLOYMENT KNOB WAS ABLE TO MOVE T2 INTO THE DEPLOYED POSITION. DEPLOYMENT OF T2 INTO A RUBBER MENISCUS WAS SUCCESSFUL. REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. IT IS UNKNOWN WHAT CAUSED THE USER TO EXPERIENCE THE REPORTED EVENT, AS THE PROBLEM WAS NOT ABLE TO BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    DURING A MENISCUS REPAIR PROCEDURE, IT WAS REPORTED THAT T1 WAS TAKEN AWAY WHEN PUSHING T1 AND THEN PULLING OUT. T2 WAS REPORTED TO NOT BE DEPLOYED. A PROCEDURAL DELAY OF LESS THAN THIRTY MINUTES WAS REPORTED AND THE PRODUCT WAS REMOVED FROM THE PATIENT. A BACKUP DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452128 ULTRA ULTRA FAST-FIX ASSEMBLY - CURVED SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 50416999

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR