BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINFIX TI 5.0 MM RC

    MDR report key: 1811599 · Received August 23, 2010

    Report

    Report Number
    1219602-2010-00218
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 22, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    DURING THE SURGERY THE SUTURE WAS SNAPPED. SO THE ANCHOR WAS REMAINED IN PATIENT¿S BODY. SO SURGEON HAS CHOSE ANOTHER ANCHOR FOR REPLACING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWINFIX TI 5.0 MM RC TWINFIX TI 5.0 ULTRABRAID MBI SMITH & NEPHEW ENDOSCOPY 72200755 50334104

    Patients

    Seq Age Sex Outcome Treatment
    1