BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINFIX ULTRA - TI ANCHOR

    MDR report key: 2851146 · Received November 29, 2012

    Report

    Report Number
    1219602-2012-00324
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    April 1, 2011
    Report Date
    November 6, 2012
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    MBI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CLASS II RECALL WAS INITIATED ON AUGUST 6, 2012 FOR SUTURE ANCHOR WITH PACKAGE INTEGRITY ISSUE. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE PATIENT RECEIVED A LEFT SHOULDER ARTHROSCOPY USING TWINFIX 3.5MM ANCHORS (LOT NUMBERS UNKNOWN). POST-OPERATIVE THE PATIENT DEVELOPED AN INFECTION AND JOINT INFLAMMATION AT THE SURGICAL SITE. IT WAS REPORTED THAT ON (B)(6) 2011 AND (B)(6) 2012 THE IMPLANTS WERE EXPLANTED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWINFIX ULTRA - TI ANCHOR TWINFIX TI 3.5 ULTRABRAID MBI SMITH & NEPHEW MANSFIELD MANUFACTURING SITE 72200752

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention