BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HFN DRILL GUIDE

    MDR report key: 6511155 · Received April 21, 2017

    Report

    Report Number
    1020279-2017-00288
    Event Type
    Malfunction
    Date Received
    April 21, 2017
    Date of Event
    March 27, 2017
    Report Date
    May 26, 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

    Additional Manufacturer Narrative · 1

    PROBLEM WITH SURGEON BEING UNABLE TO PLACE THE DISTAL INTERLOCKING SCREWS HAS BEEN REPORTED UNDER MDR 1020279-2017-00286.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERNAL THREADS FOR IMPACTOR/EXTRACTOR WERE STRIPPED PREVENTED SURGEON FROM BEING ABLE TO REMOVE THE NAIL AFTER IT WAS INSERTED. SURGEON WANTED TO EXPLANT THE NAIL DUE TO PREVIOUS FAILURE TO PLACE THE DISTAL INTERLOCKING SCREWS AND WHEN HE WAS UNABLE TO EXPLANT THE NAIL IT WAS DECIDED TO LEAVE THE NAIL IN PLACE WITHOUT THE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294324 HFN DRILL GUIDE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SMITH & NEPHEW, INC. 06MSP0005

    Patients

    Seq Age Sex Outcome Treatment
    1