BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINFIX TI 5.0 QUICK-T

    MDR report key: 1357920 · Received January 16, 2009

    Report

    Report Number
    1219602-2009-00009
    Event Type
    Malfunction
    Date Received
    January 16, 2009
    Date of Event
    December 18, 2008
    Report Date
    December 18, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIVISION
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES WERE RETURNED FOR EVALUATION. ALL DEVICES ARE MISSING THE SUTURE, T-BAR AND ANCHORS. DEVICES WERE NOT RETURNED IN THE CONDITION OF THE COMPLAINT. DEVICES APPEAR TO HAVE BEEN USED SUCCESSFULLY.

    Description of Event or Problem · 1

    SURGEON WAS PERFORMING A ROTATOR CUFF REPAIR WHEN HE DEPLOYED THE ANCHOR, T-BAR AND SUTURE. THE T-BAR APPEARED TO DEPLOY TOO DEEP INTO THE TISSUE. THIS HAPPENED ON TWO DEVICES. SURGEON LEFT THE DEVICES IN PLACE AND USED THREE ADDITIONAL DEVICES TO COMPLETE THE REPAIR AS THE FIRST TWO DEVICES DID NOT SUPPLY ADEQUATE FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWINFIX TI 5.0 QUICK-T QUICK-T MBI SMITH & NEPHEW INC., ENDOSCOPY DIVISION 72200767 50259746

    Patients

    Seq Age Sex Outcome Treatment
    1