BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINFIX AB 5.0 SUTURE ANCHOR W/2 38" ULTRBRAID

    MDR report key: 1014078 · Received March 14, 2008

    Report

    Report Number
    1219602-2008-00063
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Report Date
    February 18, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIV.
    Product Code
    MBI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED PAIN AFTER AN ANCHOR IMPLANTED IN 2007, MRI REVEALED THE ANCHOR BROKE OFF AT THE EYELET. A REVISION SURGERY WAS DONE IN 2008 TO RETRIEVE THE LOOSE ANCHOR AND SUTURE, AND ADDITIONAL ANCHOR WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWINFIX AB 5.0 SUTURE ANCHOR W/2 38" ULTRBRAID TWINFIX AB 5.0 MBI SMITH & NEPHEW INC., ENDOSCOPY DIV. 72200777 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1