BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN OLIVERCRONA-GIGLI SAW

    MDR report key: 4203818 · Received July 23, 2014

    Report

    Report Number
    3007208013-2014-00004
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    April 18, 2014
    Report Date
    July 22, 2014
    Manufacturer
    SYMMETRY SURGICAL
    Product Code
    DWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION. METHOD - A DEVICE FROM THE SAME LOT OF ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULT - VISUAL EXAMINATION OF DEVICE. NO CONCLUSION CAN BE DRAWN. CONCLUSION - USE OF DEVICE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING A TIBIAL OSTEOTOMY FOR THE CORRECTION OF THE LOWER LIMB, DURING THE PROCEDURE THE GIGLI SAW SHOWED FRAYING AND SUBSEQUENTLY BROKE. SOME FRAGMENTS/FILAMENTS OF THE SAW HAVE PENETRATE INSIDE THE BONE. NO PT ADVERSE CONSEQUENCES HAVE BEEN REPORTED. THE EVENT HAPPENED IN ITALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432536 CODMAN OLIVERCRONA-GIGLI SAW GIGLI SAW DWH SYMMETRY SURGICAL 75-1020 1792011

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR