BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-AO TORQUE LIMITING DRIVER, 10INLB

    MDR report key: 19430678 · Received May 30, 2024

    Report

    Report Number
    3025141-2024-00477
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    May 7, 2024
    Report Date
    May 29, 2024
    Manufacturer
    ACUMED, LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED 2.3MM X 18MM LOCKING CORTICAL SCREW (PART NUMBER CO-T2318) WAS NOT RETURNED FOR EVALUATION. ADDITIONALLY, MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS THE BATCH/LOT NUMBERS OF THE DEVICES ARE UNKNOWN. MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. THE REPORTED MINI-AO TORQUE LIMITING DRIVER, 10INLB (PART NUMBER 80-1008, LOT NUMBER 287919) WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE REPORTED DRIVER TIP WAS RETURNED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. THE 1.5MM HEX DRIVER TIP, LOCKING GROOVE (PART NUMBER 80-0728, BATCH NUMBER 581628) WAS EXAMINED UNDER MAGNIFICATION. TORSIONAL AND OBLIQUE FRACTURE PATTERNS WERE IDENTIFIED AT THE TRANSITION FROM THE RADIUS TO THE HEX TIP. A TORSIONAL FRACTURE PATTERN LIKELY INDICATES AN EXCESSIVE TWISTING LOAD ABOUT THE DRIVER'S CENTRAL AXIS, WHILE AN OBLIQUE FRACTURE PATTERN LIKELY INDICATES SOME SIDE LOADING (BENDING), AWAY FROM THE DRIVER'S CENTRAL AXIS, WAS ALSO APPLIED TO THE HEX TIP. HEX TIP BREAKAGE MAY OCCUR WHEN EXCESSIVE FORCE IS APPLIED TO THE DRIVER DURING USE TO OVERCOME INCREASED RESISTANCE. THIS INCREASED RESISTANCE CAN HAVE MANY CONTRIBUTING FACTORS SUCH AS ENCOUNTERING DENSE BONE OR INADEQUATE PILOT HOLE DEPTH. HOWEVER, BASED ON THE INFORMATION RECEIVED AND DUE TO UNKNOWN SURGICAL CONDITIONS, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    (REPORT 3 OF 3). IT WAS REPORTED DURING SURGERY THE SURGEON WAS INSERTING THE 2.3MM X 18MM LOCKING CORTICAL SCREW (PART NUMBER CO-T2318) INTO THE DISTAL STYLOID HOLE USING THE MINI-AO TORQUE LIMITING DRIVER, 10INLB (PART NUMBER 80-1008 LOT NUMBER 287919) WHEN THE 1.5MM HEX DRIVER TIP, LOCKING GROOVE (PART NUMBER 80-0728, LOT NUMBER 581628) SNAPPED INTO THE SCREW HEAD. THE BROKEN DRIVER TIP WAS REMOVED FROM THE SCREW AND THE SURGERY WAS COMPLETED AFTER A 2-3-MINUTE DELAY. NO OTHER ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THERE ARE 3 RELATED REPORT NUMBERS FOR THIS EVENT 3025141-2024-00475.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150062 MINI-AO TORQUE LIMITING DRIVER, 10INLB ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ACUMED, LLC 80-1008 287919

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male