BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-AO TORQUE LIMITING DRIVER, 10INLB

    MDR report key: 18179411 · Received November 20, 2023

    Report

    Report Number
    3025141-2023-00670
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    August 2, 2023
    Report Date
    November 18, 2023
    Manufacturer
    ACUMED, LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. THE RETURNED MINI-AO TORQUE LIMITING DRIVER, 10INLB WAS INSPECTED UNDER MAGNIFICATION AND FUNCTIONALLY TESTED. THERE WERE NO SIGNIFICANT SIGNS OF DAMAGE OR WEAR ACROSS THE DRIVER HANDLE. THE TORQUE LIMITING DRIVER (TLD) WAS USED WITH AN ENGINEERING LAB SAMPLE OF A DRIVER (80-0728) TO INSERT A 2.3MM VARIABLE ANGLE LOCKING SCREW INTO AN ACU-LOC 2 VDR STANDARD PLATE ON A FOAM BLOCK. ONCE SEATED, THE DRIVER SHOULD CLICK, LIMITING THE TORQUE APPLIED TO THE DRIVER AND SCREW. ONCE THE SAMPLE SCREW WAS SEATED, THE HANDLE DID NOT CLICK BUT INSTEAD SKIPPED AND STOPPED TURNING THE SCREW. IT SEEMS THAT THE TORQUE LIMITING MECHANISM INSIDE THE DRIVER HANDLE WAS NO LONGER FUNCTIONING. THE INTERNAL MECHANISMS OF THE TLD COULD NOT BE INSPECTED WITHOUT DESTRUCTIVE TESTING. THE SURGICAL TECHNIQUE ADVISES AGAINST USING THE TLD TO REMOVE SCREWS AS THE COUNTERCLOCKWISE MOTION CAN UNSCREW THE INTERNAL MECHANICS OF THE TLD. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    ON 08 AUGUST 2023, A PART NUMBER 80-1008 TORQUE LIMITING DRIVER WAS RETURNED WITH A NOTE STATING IT WAS MALFUNCTIONING. NO FURTHER INFORMATION WAS PROVIDED, AND FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE PERFORMED TO NO AVAIL. ADDITIONAL INFORMATION WAS RECEIVED ON 14 NOVEMBER 203: IT WAS REPORTED DURING SURGERY, WHILE USING THE PART NUMBER 80-1008 TORQUE LIMITING DRIVER TO IMPLANT THE 2.3 DISTAL SCREWS IN THE ACULOC PLATE, THE 80-1008 WAS NOT WORKING PROPERLY AS IT WAS STRIPPING SCREWS. SWITCHING TO AN OLDER GENERATION "ORANGE HANDLE" 80-1008 TORQUE LIMITING DRIVER RESOLVED THE ISSUE. TO COMPLETE THE SURGERY, THE STRIPPED SCREWS WERE REMOVED, AND NEW SCREWS WERE IMPLANTED USING THE "ORGANGE HANDLE" 80-1008. IT WAS REPORTED THIS ISSUE PROLONGED THE SURGERY BY 10-15 MINUTES AND RESULTED IN LONGER TIME UNDER ANESTHESIA FOR THE PATIENT. THIS REPORT IS RELATED TO REPORT NUMBERS 3025141-2023-00671 AND 3025141-2023-00672 FOR THE OTHER DEVICES INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2069746 MINI-AO TORQUE LIMITING DRIVER, 10INLB ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ACUMED, LLC 80-1008 495137

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Unknown