BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXION IM FEMORAL NAIL

    MDR report key: 6857301 · Received September 12, 2017

    Report

    Report Number
    9615128-2017-00038
    Event Type
    Malfunction
    Date Received
    September 12, 2017
    Date of Event
    January 5, 2017
    Report Date
    May 17, 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

    AS INDICATED IN THE SYSTEM IFU, THE NAIL SHOULD BE EXPENDED TO 50 BARS, AND IF AT THAT STAGE ABUTMENT OF THE NAIL BARS TO THE MEDULLARY CANAL WALLS IS NOT EVIDENT RADIOGRAPHICALLY, THE NAIL SHOULD BE FURTHER EXPANDED UP TO 70 BAR (MAXIMAL PRESSURE SHOULD NOT EXCEED 70 BAR). THE NAIL WAS PROBABLY NOT SUFFICIENTLY EXPANDED. (B)(4). NOTE: THIS PRODUCT IS NO LONGER MARKETED IN THE USA.

    Description of Event or Problem · 1

    PRIOR THE IMPLANTATION THE NAIL HELD PRESSURE (25 BAR) FOR 3 MINUTES WITH NO LEAKAGE. DURING IMPLANTATION OF A FIXION IM FEMORAL NAIL IN (B)(6), THE X-RAY SHOWED NO EXPANSION WHEN THE NAIL WAS PRESSURIZED TO 25 BAR AND 50 BAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637096 FIXION IM FEMORAL NAIL INTRAMEDULLARY ROD SYSTEM HSB CARBOFIX ORTHOPEDICS LTD. FXN01094

    Patients

    Seq Age Sex Outcome Treatment
    1