BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI MAXLOCK EXTREME

    MDR report key: 7112350 · Received December 13, 2017

    Report

    Report Number
    3000931034-2017-00174
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    September 7, 2017
    Report Date
    September 10, 2017
    Manufacturer
    TORNIER S.A.S.
    Product Code
    HXX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. THOUGH THIS DEVICE IS NOT COMMERCIALLY AVAILABLE FOR SALE IN THE US, IT IS SIMILAR TO A DEVICE CURRENTLY MARKETED FOR SALE IN THE US.

    Description of Event or Problem · 1

    DURING THE SURGERY, THE TIPS OF THE TWO HEXSTAR DRIVER BROKE INSIDE THE SCREW HEAD. IT WAS VERY DIFFICULT FOR THE SURGEON TO REMOVE THE MTP FUSION PLATE FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894629 MINI MAXLOCK EXTREME SCREWDRIVER HXX TORNIER S.A.S. TOURNEVIS HEXSTAR¿

    Patients

    Seq Age Sex Outcome Treatment
    1 Other