BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADV HEALING - TWINFI

    MDR report key: 3926396 · Received July 10, 2014

    Report

    Report Number
    1219602-2014-00197
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 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

    ALTHOUGH ANTICIPATED, THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. (B)(4).

    Additional Manufacturer Narrative · 1

    ONE 4.5 TWINFIX ULTRA HA ASSEMBLY WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE DEVICE CONFIRMED THE REPORTED COMPLAINT OF ANCHOR BREAKAGE. THE BREAK IS ANGULAR IN NATURE AND EMANATES AT THE TOP SUTURE EYELET. THE SUTURE IS PARTIALLY OUT OF THE INSERTER. ONE OF THE TWO INSERTER TINES IS BROKEN FREE AND WAS NOT RETURNED FOR EVALUATION. THE TINE THAT REMAINS ATTACHED TO THE INSERTER IS BENT, INDICATIVE OF OFF- AXIS INSERTION. DUE TO THE LIMITED CLINICAL DETAILS REGARDING BONE QUALITY A ROOT CAUSE CANNOT BE DETERMINED. 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

    DURING ROTATOR CUFF PROCEDURE, THE ANCHOR BROKE AS THE SURGEON WAS PUTTING IT IN. SOME OF THE ANCHOR WAS LEFT IN THE PATIENT AS THE SURGEON COULD NOT REMOVE IT. THE SITE WOULD HAVE BEEN PREPARED USING AWL/DILATOR. BONE QUALITY IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403907 ADV HEALING - TWINFI TWINFIX ULTRA HA 4.5 W/2 UB MAI MANSFIELD MANUFACTURING SITE 72202624 50495050

    Patients

    Seq Age Sex Outcome Treatment
    1