BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINFIX 6.5 AB PRLD STR ANCHOR W/ 2 NDLS

    MDR report key: 1082893 · Received July 25, 2008

    Report

    Report Number
    1219602-2008-00163
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Report Date
    June 19, 2008
    Manufacturer
    SMITH & NEPHEW INC. ENDOSCOPY DIV.
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED WITH ONE ANCHOR THREAD REMAINING ON ONE SIDE OF THE SUTURE AND THREE THREADS REMAINING ON THE OTHER SIDE. SUTURE REMAINS INTACT WITH THE HANDLE. NO CONCLUSION COULD BE MADE FOR THE REPORTED FAILURE.

    Description of Event or Problem · 1

    DURING A BICEPS REPAIR, PART OF THE ANCHOR WAS EMBEDDED IN THE BONE. THE SURGEON USED A DILATOR AND ALSO PRE-DRILLED WITH A 5.5MM DRILL. THE ANCHOR WAS PLACED IN THE BICEPS GROOVE. A 10-MINUTE DELAY WAS EXPERIENCED WHILE ATTEMPTING TO REMOVE THE ANCHOR, AND GATHER A BACK-UP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWINFIX 6.5 AB PRLD STR ANCHOR W/ 2 NDLS TWINFIX ANCHOR MBI SMITH & NEPHEW INC. ENDOSCOPY DIV. 7210713 50242809

    Patients

    Seq Age Sex Outcome Treatment
    1