BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1010-38 A.I.M. FEMORAL NAIL

    MDR report key: 166685 · Received May 6, 1998

    Report

    Report Number
    2020311-1998-00004
    Event Type
    Injury
    Date Received
    May 6, 1998
    Date of Event
    June 20, 1997
    Report Date
    March 11, 1998
    Manufacturer
    DEPUY ACE MEDICAL CO.
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FEMUR BROKE (LINEAR FRACTURE) ON REMOVAL OF NAIL. SURGEON FORCED THE NAIL TO COME OUT EVEN AFTER A DIFFICULTY IN REMOVING HAD BEEN EXPERIENCED. PHYSICIAN SPECULATES THAT THE "BONE IN THE SLOT HAS MADE THE NAIL HARD TO REMOVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1010-38 A.I.M. FEMORAL NAIL Implant INTRAMEDULLARY ROD HSB DEPUY ACE MEDICAL CO. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR