BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAG 3.7MM ROD II

    MDR report key: 1792156 · Received August 10, 2010

    Report

    Report Number
    1219602-2010-00206
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 2, 2010
    Report Date
    July 7, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURING
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SMALL PIECE OF THE ANCHOR WAS RETURNED FOR EVALUATION. THE ANCHOR BROKE AT THE SUTURE EYELET. THE ANCHOR APPEARS TO BE SLIGHTLY BENT. THE BREAK IS ANGULAR IN NATURE. THERE IS NO DAMAGE TO THE PROXIMAL END OF THE ANCHOR. CONDITION OF THE ANCHOR IS CONSISTENT WITH OFF AXIS INSERTION. (B)(4).

    Description of Event or Problem · 1

    DURING SHOULDER SURGERY, DR WAS INSERTING A TAG SUTURE ANCHOR USING ARTHREX TIGER WIRE AS THE SUTURE MATERIAL. AS HE WAS PULLING ON THE SUTURE THE TAG ANCHOR FRACTURED IN HALF AND PART WAS LEFT IN THE PATIENT. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAG 3.7MM ROD II TAG 3.7MM ROD II MBI SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURING 014349 50319366

    Patients

    Seq Age Sex Outcome Treatment
    1