BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 3082430 · Received March 27, 2013

    Report

    Report Number
    3082430
    Date Received
    March 27, 2013
    Date of Event
    December 26, 2012
    Report Date
    February 14, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 5-INCH LONGITUDINAL SKIN INCISION WAS MADE VOLARLY, AND A VOLAR HENRY APPROACH WAS MADE TO THE VOLAR RADIUS. A 6-HOLE SYNTHES PLATE WAS EXPOSED AND REMOVED. SIX SCREWS WERE REMOVED. ONE SCREW BROKE, AND A PORTION OF THE SCREW SHAFT WAS NOT ABLE TO BE REMOVED. THE WOUND WAS IRRIGATED AND CLOSED WITH 2-0 VICRYL FOLLOWED BY STAPLES. AN ADDITIONAL 4-INCH SKIN INCISION WAS MADE VOLARLY, AND A SUBCUTANEOUS APPROACH TO THE ULNAR WAS PERFORMED. AN ADDITIONAL SIX-HOLE SYNTHES PLATE AND SIX SCREWS WERE REMOVED, ONE OF THESE SCREWS ALSO BROKE, AND A PORTION OF THAT SCREW WAS NOT ABLE TO BE REMOVED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?REMOVE PLATE AND SCREWS, LEFT FOREARM.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127287 * SCREW, FIXATION, BONE HWC SYNTHES USA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR