BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINFIX TI 5.0 ANCHOR W/DURABRAID

    MDR report key: 1162805 · Received September 8, 2008

    Report

    Report Number
    1219602-2008-00214
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    July 29, 2008
    Report Date
    August 7, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIVISION
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    SUTURE SNAPPED/BROKE DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR. OR NURSE MANAGER CONFIRMED THAT THERE WERE FOUR ANCHORS IN ALL, THAT THE SUTURE BROKE. SHE DID NOT KNOW THE DETAILS OF WHEN THE SUTURE BROKE (DURING TIGHTENING OR AFTER THE KNOT WAS TIGHTENED), BUT DID KNOW THAT ALL FOUR ANCHORS REMAIN IN THE PATIENT UNSECURED WITH SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWINFIX TI 5.0 ANCHOR W/DURABRAID TWINFIX MBI SMITH & NEPHEW INC., ENDOSCOPY DIVISION 72200766 50215550

    Patients

    Seq Age Sex Outcome Treatment
    1 NA