BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5MM TWINFIX AB SUTURE ANCHOR W/NEEDLES

    MDR report key: 990111 · Received January 23, 2008

    Report

    Report Number
    1219602-2008-00016
    Event Type
    Malfunction
    Date Received
    January 23, 2008
    Date of Event
    November 2, 2007
    Report Date
    November 16, 2007
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIV.
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ROTATOR CUFF SURGERY THE ANCHOR BROKE. ADDITIONAL INFO PROVIDED 12/19/2007. THE DR DID NOT REMOVE THE ANCHOR AND FINISHED WITHOUT INJURY OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.5MM TWINFIX AB SUTURE ANCHOR W/NEEDLES TWINFIX AB MBI SMITH & NEPHEW INC., ENDOSCOPY DIV. 7210712 501469

    Patients

    Seq Age Sex Outcome Treatment
    1