BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXTAR SPINE MUST SCREWDRIVER - SHORT

    MDR report key: 18011498 · Received October 26, 2023

    Report

    Report Number
    3005180920-2023-00841
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Date of Event
    September 26, 2023
    Report Date
    February 29, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OLO
    UDI-DI
    07630345728968
    PMA / PMN Number
    K210859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON 29 FEBRUARY 2024, DURING A CHECK, WE HAVE FOUND TWO ERRORS IN THE INITIAL MDR REPORT (MDR 2023-00841): LABELED FOR SINGLE USE?: IT IS WRITTEN "YES" BUT IT HAS TO BE "NO". USAGE OF DEVICE: IT IS WRITTEN "INITIAL USE" BUT IT HAS TO BE "REUSE".

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03-OCTOBER-2023. LOT 2252515: (B)(4) MANUFACTURED AND RELEASED ON 18-OCT-2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, THREE OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: FROM THE INFORMATION AVAILABLE AND THE DEVICE RECEIVED, IT IS POSSIBLE THAT THERE WAS A SUBOPTIMAL PREPARATION OF THE BONE FOR THE SCREW INSERTION (NO TAPPING FOR THE ENTIRE LENGHT OF THE SCREW WAS PERFORMED) THAT CAUSED THE TIP'S BREAKAGE.

    Description of Event or Problem · 0

    DURING A NEXTAR CASE, WHILE INSERTING S2AI SCREW (10X100MM), THE TIP OF NEXTAR SPINE MUST SCREWDRIVER - SHORT BROKE. NO SCREW WAS INSERTED IN S2AI AND THE SURGERY WAS COMPLETED SUCCESSFULLY. TAPPING WAS PERFORMED USING REFERENCES 03.51.10.0438 -> 03.51.10.0439 -> 03.51.10.0440. ALL FRAGMENTS WERE REMOVED. DELAY TIME 30 MIN. TOTAL SURGERY TIME 7H. THE DELAY WAS DUE TO THE TIME NECESSARY TO RETRIEVE THE FRAGMENTS OF THE TIP OF SCREWDRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674047 NEXTAR SPINE MUST SCREWDRIVER - SHORT SPINE INSTRUMENT OLO MEDACTA INTERNATIONAL SA 2252515 07630345728968

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Other