BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-AO TORQUE LIMITING DRIVER, 10INLB

    MDR report key: 18077463 · Received November 6, 2023

    Report

    Report Number
    3025141-2023-00617
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Report Date
    November 5, 2023
    Manufacturer
    ACUMED, LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DRIVER MINI-AO TORQUE LIMITING DRIVER, 10INLB (PART NUMBER 80-1008) WAS NOT RETURNED FOR EVALUATION. ADDITIONALLY, MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS THE BATCH/LOT NUMBER OF THE DRIVER IS UNKNOWN. HOWEVER, MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND FOR THE 1ST 1.5MM HEX DRIVER TIP, LOCKING GROOVE (PART NUMBER 80-0728, LOT NUMBER 593243). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A SURGERY "ACULOC 2 CASE - TWO OF THE NEW STYLE 1.5 DRIVERS BROKE DURING INSERTION OF 2.3 LOCKING SCREWS INTO DISTAL RADIUS PLATE. THE TORQUE LIMITING DRIVER WAS USED WITH THE DRIVER TIPS. CAUSED A FEW MINUTE DELAY. PATIENT WAS STABLE." THE SURGERY WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THIS REPORT IS RELATED TO REPORT NUMBERS 3025141-2023-00615 AND 3025141-2023-00616 FOR THE OTHER DRIVERS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348654 MINI-AO TORQUE LIMITING DRIVER, 10INLB ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ACUMED, LLC 80-1008

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown