BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLS NOETOS SAW BLADE

    MDR report key: 6208388 · Received December 28, 2016

    Report

    Report Number
    3000931034-2016-00231
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    December 7, 2016
    Report Date
    December 7, 2016
    Manufacturer
    TORNIER S.A.S.
    Product Code
    GFA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAW BLADE BROKE DURING SURGERY, FRAGMENTS REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858828 HLS NOETOS SAW BLADE SURGICAL SAW BLADE GFA TORNIER S.A.S. FOR HALL-LINVATEC CONNECTOR 15E538

    Patients

    Seq Age Sex Outcome Treatment
    1 Other