BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TRAUMA FIXATION SCREW

    MDR report key: 7517895 · Received May 16, 2018

    Report

    Report Number
    0001825034-2018-03393
    Event Type
    Injury
    Date Received
    May 16, 2018
    Date of Event
    September 10, 2012
    Report Date
    September 12, 2018
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HWC
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCT WAS NOT EVALUATED, BUT THE REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF OPERATIVE RECORDS. A DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED EVENT IS UNKNOWN. 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). IT HAS BEEN INDICATED BY THE CUSTOMER THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE LOCATION OF THE PRODUCT CURRENTLY REMAINS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS - 2.2MM X 28 GUIDE WIRE CATALOG #: 8092-22-028 LOT #: E2PAG7, ENDCAP IMPINGING CATALOG #: 8007-00-000 LOT #: DLDBCF, VERSANAIL TIBIOTALOCALCANEAL ANKLE FUSION NAIL CATALOG #: 800710025 LOT #: DLNCL1. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT; PLEASE SEE ASSOCIATED REPORTS: 0001825034-2014-00546, 0001825034-2017-02592, 0001825034-2018-03394. INADEQUATE INFORMATION RECEIVED.

    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
    362033 UNKNOWN TRAUMA FIXATION SCREW SCREW, FIXATION HWC BIOMET TRAUMA N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R