BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINFIX

    MDR report key: 3844934 · Received June 3, 2014

    Report

    Report Number
    1219602-2014-00168
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MANSFIELD MANUFACTURING SITE
    Product Code
    MAI
    PMA / PMN Number
    K093844
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE TWINFIX ULTRA HA 4.5 ANCHOR ASSEMBLY WAS RETURNED FOR EVALUATION. THE SUTURE AND ANCHOR ARE FREE FROM THE INSERTER. THE ANCHOR IS BROKEN ABOVE THE SUTURE SLOT/EYELET AND ALL PIECES ARE ACCOUNTED FOR. AS REPORTED, THE PATIENT HAD HARD BONE AND THE SITE WAS PREPPED USING THE AWL/DILATOR, THE IFU STATES TO USE A DRILL TO CREATE A PILOT HOLE FOR THE ANCHOR, THEN INSERT THE AWL-DILATOR TO BETTER PREPARE THE BONE FOR THE ANCHOR IN HARD BONE APPLICATIONS. A REVIEW OF THE DEVICE HISTORY RECORDS ASSOCIATED WITH THIS MANUFACTURED LOT SHOW THAT NO ABNORMALITIES WERE REPORTED WITH THIS PRODUCT LOT DURING MANUFACTURE. DUE TO THESE OBSERVATIONS, NO ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS CAN BE ESTABLISHED. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    TWO TWINFIX ANCHORS (DIFFERENT LOT # REF: (B)(4)) BROKE AT THE TIP DURING INSERTION. THE PATIENT HAD HARD BONE AND THE TAP AND AWL/DILATOR WAS USED; NO DRILL. THERE WAS NOTHING LEFT IN THE PATIENT AND THE PATIENT WAS FINE AFTER THE PROCEDURE. SALES REP. STATES THERE WAS A BACKUP ANCHOR USED AND TO MY KNOWLEDGE THE SAME HOLE WAS USED, BUT I AM NOT 100% SURE OF THAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323608 TWINFIX TWINFIX ULTRA HA 4.5 W/2 UB MAI MANSFIELD MANUFACTURING SITE 72202624 50489163

    Patients

    Seq Age Sex Outcome Treatment
    1