BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARX SAI

    MDR report key: 22030161 · Received May 15, 2025

    Report

    Report Number
    3004499989-2025-00007
    Event Type
    Malfunction
    Date Received
    May 15, 2025
    Date of Event
    April 10, 2025
    Report Date
    May 15, 2025
    Manufacturer
    LIFE SPINE
    Product Code
    NKB
    UDI-DI
    00190837073671
    PMA / PMN Number
    K241464
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DRIVE TIP BROKE IN THE SCREW AND QUICKLY WAS RETRIEVED AND CAUSED NO SURGICAL DELAYS OR EFFECTS ON PATIENTS. THE SURGEON HAD BOTTOM OUT THE SCREW AND HAD KEPT TORQUING THE SCREW DRIVER, THE DRIVER WAS STUCK BETWEEN THE TULIP OF THE SCREW AND PATIENT BONE WITH THE ADDITIONAL TORQUE CAUSED UNDUE STRESS ON THE DRIVER TIP.

    Description of Event or Problem · 0

    IT WAS STATED THAT "THE INSTRUMENTS BROKE WITH NORMAL USE. ONE DRIVER LOCKED ON THE T-HANDLE WHILE IMPLANTING A SCREW AND THE OTHER DRIVER TIP BROKE WHILE IMPLANTING A SCREW. THEY WERE IMPLANTING THE FIRST SAI SCREW WHEN THE T-HANDLE SEIZED UP ON THE DRIVER AFTER THE SCREW BOTTOMED OUT AND THEY COULDN'T GET IT OFF. THE SECOND DRIVER WAS THEN USED TO IMPLANT A SECOND SAI SCREW AND AS IT BOTTOMED OUT, THE TIP OF THE DRIVER BROKE OFF. THEY WERE ABLE TO RETRIEVE THE PIECE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88784 ARX SAI DRIVER NKB LIFE SPINE 175-147 CNW24111 00190837073671

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention