BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSANAIL TIBIOTALOCALCANEAL ANKLE FUSION NAIL

    MDR report key: 6495944 · Received April 15, 2017

    Report

    Report Number
    0001825034-2017-02592
    Event Type
    Injury
    Date Received
    April 15, 2017
    Date of Event
    September 10, 2012
    Report Date
    September 12, 2018
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HSB
    PMA / PMN Number
    PK023115
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW AND THE REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF OPERATIVE RECORDS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. OPERATIVE RECORDS PROVIDED CONFIRM THAT THE PATIENT UNDERWENT AN ANKLE PROCEDURE TO REMOVE THE INTRAMEDULLARY ROD AND LOCKING SCREWS DUE TO PAINFUL HARDWARE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO COMPLICATIONS. BASED ON THE LIMITED INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. CONCOMITANT DEVICES: - 2.2MM X 28 GUIDE WIRE, CATALOG #: 8092-22-028, LOT #: E2PAG7. ENDCAP IMPINGING, CATALOG #: 8007-00-000, LOT #: DLDBCF. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034-2014-00546).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND MALUNION, FIRST NOTED APPROXIMATELY TWO MONTHS FOLLOWING REMOVAL OF A MIGRATED DISTAL SCREW. SUBSEQUENTLY, PATIENT UNDERWENT AN ANKLE FUSION NAIL REVISION DUE TO PAIN AND DELAYED UNION APPROXIMATELY 1.5 YEARS POST-IMPLANTATION. ALL COMPONENTS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277984 VERSANAIL TIBIOTALOCALCANEAL ANKLE FUSION NAIL ROD, FIXATION HSB BIOMET TRAUMA N/A DLNCL1

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R