BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES USA

    MDR report key: 112764 · Received August 12, 1997

    Report

    Report Number
    112764
    Event Type
    Injury
    Date Received
    August 12, 1997
    Date of Event
    July 16, 1997
    Report Date
    July 21, 1997
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    39 YR MALE ADMITTED VIA ER AFTER 20' FALL WITH LEFT FEMUR FX. DURING ORIF LEFT FEMUR FX, THE FLUTED PORTION OF THE REAMOR SEPARATED FROM THE SHAFT, WHEN THE REAMER WAS PLACED IN REVERSE, TO BACK IT OUT. THE SURGEON WAS UNABLE TO RETRIEVE THE REAMOR HEAD, AND THE WOUND WAS THEN CLOSED, ORIF ABORTED. THE PT WAS TRANSFERRED ON 7/18/97. SUCCESSFUL RETRIEVAL OF REAMERHEAD FRAGMENT COMPLETED ON 7/20/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES USA Implant REAMER HTW SYNTHES (USA) 3381.10 8.0 MM DRILL BIT *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R