BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HFN DROP

    MDR report key: 6510919 · Received April 21, 2017

    Report

    Report Number
    1020279-2017-00286
    Event Type
    Malfunction
    Date Received
    April 21, 2017
    Date of Event
    March 27, 2017
    Report Date
    June 8, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HSB
    PMA / PMN Number
    K122170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FEMORAL NAIL WAS IMPLANTED WITHOUT ANY DISTAL INTERLOCKING SCREW AS TARGETED DISTAL SCREWS WERE MISSING THE HOLES IN THE NAIL MAKING THE SURGEON UNABLE TO PLACE THEM. IT WAS REPORTED THAT THE HFN DROP DEVICE IS CONSIDERED TO HAVE MALFUNCTIONED AND CONTRIBUTED TO THIS LACK OF SCREW PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294337 HFN DROP ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SMITH & NEPHEW, INC. 07EGT0004

    Patients

    Seq Age Sex Outcome Treatment
    1