BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-AO TORQUE LIMITING DRIVER, 10INLB

    MDR report key: 20873035 · Received December 6, 2024

    Report

    Report Number
    3025141-2024-00739
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    November 15, 2024
    Report Date
    December 6, 2024
    Manufacturer
    ACUMED, LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED MINI-AO TORQUE LIMITING DRIVER, 10INLB WAS NOT RETURNED FOR EVALUATION. ADDITIONALLY, MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS THE MINI-AO TORQUE LIMITING DRIVER, 10INLB (PART NUMBER 80-1008) BATCH/LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING SURGERY THAT WHEN THE SURGEON WAS USING THE MINI TORQUE LIMITING DRIVER TO INSERT THE DISTAL SCREWS IN THE PLATE THE DRIVER TIP BROKE INSIDE THE HANDLE. IT WAS ALSO REPORTED NO METAL WAS LEFT INSIDE THE PATIENT. THE SURGERY WAS COMPLETED WITH A DIFFERENT DRIVER AFTER A 5-MINUTE DELAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2517498 MINI-AO TORQUE LIMITING DRIVER, 10INLB ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ACUMED, LLC 80-1008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown