BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINFIX ULTRA - TI

    MDR report key: 2578447 · Received May 17, 2012

    Report

    Report Number
    1219602-2012-00117
    Event Type
    Malfunction
    Date Received
    May 17, 2012
    Date of Event
    April 19, 2012
    Report Date
    April 19, 2012
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE INSERTER WAS RECEIVED WITHOUT THE BROKEN ANCHORS; THEREFORE NO CONCLUSION COULD BE MADE FOR THE REPORTED DEVICE FAILURE. (B)(4).

    Description of Event or Problem · 1

    AS ANCHOR WAS BEING INSERTED INTO THE PREPARED OPERATIVE SITE, ANCHOR BROKE LEAVING THE BODY OF THE ANCHOR SEATED IN THE BONE AND THE EYELETS SITTING IN THE DRIVER. PIECE OF ANCHOR IN THE BONE WAS REMOVED BY THE SURGEON WHO DRILLED 3, 2MM HOLES SURROUNDING THE IMBEDDED PIECE, INSERTING VICE GRIPS INTO THE HOLES, GRASPING THE BROKEN PIECE OF THE ANCHOR AND REMOVING THE PIECE. MITEK II ANCHOR WAS USED AS A BACK UP. PIECES WILL BE RETURNED TO SN FOR EVALUATION. ON (B)(6) SPOKE WITH (B)(6) (SALES REP) FOR ADDITIONAL INFORMATION: SURGEON ROUTINELY USES THE AO-2 FINGER TECHNIQUE; SURGEON USED A 1.8MM DRILL BIT THAT IS RECOMMENDED FOR THIS PRODUCT; AFTER SURGEON REMOVED THE BROKEN PIECE FROM PATIENT THE HOLE WAS NO LONGER FEASIBLE FOR IMPLANTS; SURGEON DRILLED ANOTHER HOLE AND INSERTED A MITEK ANCHOR TO COMPLETE THE PROCEDURE. BROKEN PIECES WERE RETURNED TO OKC SHORTLY AFTER DATE OF INCIDENT; THE PIECE THAT WAS REMOVED FROM THE PATIENT ALONG WITH THE PIECE THAT REMAINED IN THE DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWINFIX ULTRA - TI TWINFIX TI 2.8 ULTRABRAID MBI SMITH & NEPHEW MANSFIELD MANUFACTURING SITE 72200750 5040249

    Patients

    Seq Age Sex Outcome Treatment
    1