BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXION IM FEMUR NAIL

    MDR report key: 6857295 · Received September 12, 2017

    Report

    Report Number
    9615128-2017-00037
    Event Type
    Malfunction
    Date Received
    September 12, 2017
    Date of Event
    September 1, 2016
    Report Date
    May 9, 2017
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    HSB
    PMA / PMN Number
    K010901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE DISTRIBUTOR'S VIDEO, IT SEEMS THAT THERE WAS A SMALL CRACK IN THE NAIL MEMBRANE (AND FROM THERE THE NAIL LEAKED). IT IS DIFFICULT TO CONCLUDE WHAT CAUSED THE REPORTED FAULT' AS DURING MANUFACTURING ALL NAILS ARE INSPECTED FOR PROPER PRESSURE HOLDING DURING PRODUCTION. NOTE: THIS PRODUCT IS NO LONGER MARKETED IN THE USA.

    Description of Event or Problem · 1

    DURING IMPLANTATION OF A FIXION IM FEMORAL NAIL IN (B)(6) THE NAIL DID NOT EXPAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637077 FIXION IM FEMUR NAIL INTRAMEDULLARY FIXATION ROD SYSTEM HSB CARBOFIX ORTHOPEDICS LTD. FXN00905

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR