BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEO SCREW

    MDR report key: 6092815 · Received November 10, 2016

    Report

    Report Number
    3010470577-2016-09291
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    September 19, 2016
    Report Date
    October 20, 2016
    Manufacturer
    IN2BONES SAS
    Product Code
    HRS
    UDI-DI
    03760225713594
    PMA / PMN Number
    K160995
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATCH RECORDS OF THE 2 SCREWS LOT HAVE BEEN REVIEWED AND SHOW NO DISCREPANCY. THE 2 BROKEN SCREW HEADS WILL BE RETURNED BY THE HOSPITAL TO IN2BONES FOR INVESTIGATION. THE USE OF NON-LOCKING SCREWS IN THE NEOVIEW SYSTEM IS RECOMMENDED, ON THE PROXIMAL PART, ONLY IN THE OBLONG HOLE IN ORDER TO ADJUST PEROPERATIVELY THE POSITIONING OF THE PLATE. ON THE DISTAL PART, A SECOND NON-LOCKING SCREW MAY BE USE FOR THE RECOIL AND REDUCTION OF THE BONE ON THE PLATE BEFORE FINAL FIXATION. IN ALL CASES, IT IS RECOMMENDED TO USE A MAXIMUM OF 2 NON-LOCKING SCREWS ON THE FITING ASSEMBLY (INCLUDING ONE IN THE OBLONG HOLE). IN THIS PARTICULAR CASE, IT SEEMS THAT THE 2 BROKEN NON-LOCKING SCREWS WERE USED FOR THE FINAL FIXATION OF THE PROXIMAL PART OF THE PLATE, BESIDE THE OBLONG HOLE.

    Description of Event or Problem · 1

    WRIST SURGERY: THE NEOVIEW PLATE-SCREW SYSTEM IS INDICATED FOR FIXATION OF INTRA-ARTICULAR AND EXTRA-ARTICULAR FRACTURES OF THE DISTAL RADIUS AND RECONSTRUCTION OF THE DISTAL RADIUS. IT HAS BEEN REPORTED TO IN2BONES THAT 2 NON-LOCKING SCREWS BROKE WHEN BEING INSERTED DURING THE FIXATION OF THE PROXIMAL PART OF THE PLATE. EACH SCREW BODY REMAIN IN THE PATIENT AND 2 ADDITIONAL SCREWS HAVE BEEN IMPLANTED TO SECURE THE FIXATION OF THE PROXIMAL PART OF THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744114 NEO SCREW SCREW FOR PLATE FIXATION HRS IN2BONES SAS W27 ST014 1603020 03760225713594

    Patients

    Seq Age Sex Outcome Treatment
    1 Other OTHER SCREW REFERENCE W27 ST012, LOT 1512140