BEUDAMED
    FDA Adverse Event Other Summary report: N

    TI 5.0 QUICK-T FIXATION SYSTEM

    MDR report key: 577665 · Received March 1, 2005

    Report

    Report Number
    1219602-2005-00038
    Event Type
    Other
    Date Received
    March 1, 2005
    Date of Event
    February 2, 2005
    Report Date
    March 1, 2005
    Manufacturer
    SMITH & NEPHEW INC. ENDOSCOPY DIVISION
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SALES REPRESENTATIVE STATED THAT THE PT WAS ORIGINALLY OPERATED ON IN OCTOBER OF 2004 AND AT THAT TIME PT HAD SURGERY FOR A ROTATOR CUFF REPAIR. THE SURGEON IMPLANTED A 5.0 TWINFIX QUICK-T SYSTEM WITHOUT ANY ISSUES. THE PT CALLED THE SURGEON ABOUT TWO WEEKS AGO COMPLAINING OF A CLICKING IN THEIR SHOULDER. THE SURGEON SCOPED THEIR SHOULDER. IN 2005 AND FOUND THA TTHE SUTURE HAD BROKEN AND THE T HAD FIPPED OVER. THE T AND THE SUTURE WERE REMOVED FROM THE PT. MARK STATED THAT THE PT IS CURRENTLY DOING FINE. SALES REP. STATED THAT WHEN THE SURGEON REMOVED THE BROKEN SUTURE AND T, THAT THE REPAIR WAS HEALED AND THEREFORE NO ADDITIONAL DEVICES WERE NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI 5.0 QUICK-T FIXATION SYSTEM QUICK-T MBI SMITH & NEPHEW INC. ENDOSCOPY DIVISION 7209407 5005182

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention