BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM HEX DRIVER TIP, LOCKING GROOVE

    MDR report key: 17164272 · Received June 20, 2023

    Report

    Report Number
    3025141-2023-00333
    Event Type
    Malfunction
    Date Received
    June 20, 2023
    Date of Event
    May 25, 2023
    Report Date
    June 19, 2023
    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

    MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. THE RETURNED PRODUCTS WERE EXAMINED UNDER MAGNIFICATION. THE TORQUE LIMITING DRIVER (PART NUMBER 80-1008) WAS CONFIRMED TO HAVE BATCH NUMBER 285217. NO VISUAL DAMAGE TO THE BODY OR MECHANISM WAS FOUND. THE DRIVER WAS REPORTED TO HAVE AN ISSUE WITH THE TORQUE LIMITING FUNCTION. THE TORQUE VALUE WAS TESTED WITH A TORQUE GAGE DRIVER. THE GAGE DRIVER WAS SET AT 10 INCH POUNDS, AND CLICKED WHEN THE TORQUE LIMITING DRIVER WAS TURNED, INDICATING THAT THE TORQUE LIMITING DRIVER IS SET ABOVE 10 IN-LBS, WHICH IS ABOVE THE TARGET SETTING. THIS IS CONSISTENT WITH THE BROKEN DRIVERS, WHICH ARE RATED TO BE USED WITH 10 IN-LBS OF FORCE. A VISUAL EXAMINATION UNDER MAGNIFICATION OF THE RETURNED DRIVERS (PART NUMBER 80-0728) WAS PERFORMED. ONE DRIVER TIP FRAGMENT WAS RECEIVED, BUT IT IS NOT KNOWN TO WHICH DRIVER IT BELONGS. THE FIRST TWO RETURNED DRIVERS WERE CONFIRMED TO HAVE BATCH NUMBER 568121. THE OVERALL DRIVER LENGTHS WERE MEASURED USING TO CONFIRM THE FRACTURE POINT. THE FIRST DRIVER MEASURED 2.687 INCHES, INDICATING THAT APPROXIMATELY 0.063 INCHES OF THE DRIVER BROKE OFF. THE SECOND DRIVER MEASURED 2.681 INCHES, INDICATING THAT APPROXIMATELY 0.069 INCHES OF THE DRIVER BROKE OFF. THE OTHER DRIVER WAS CONFIRMED TO HAVE BATCH NUMBER 437694. THE OVERALL DRIVER LENGTH WAS MEASURED TO CONFIRM THE FRACTURE POINT. THE DRIVER MEASURED 2.685 INCHES, INDICATING THAT APPROXIMATELY 0.065 INCHES OF THE DRIVER BROKE OFF. ALL THREE HAD THE SAME FRACTURE LOCATION AND PATTERN. A TORSIONAL FRACTURE PATTERN WAS FOUND AT THE RADIUS WHERE THE SHAFT TRANSITIONS INTO THE HEX FOR THE DRIVER. A TORSIONAL FRACTURE PATTERN LIKELY INDICATES AN EXCESSIVE TWISTING LOAD (TORSION). HEX TIP BREAKAGE MAY OCCUR WHEN EXCESSIVE FORCE IS APPLIED TO THE DRIVER DURING USE TO OVERCOME INCREASED RESISTANCE. THE REPORTED EVENT WAS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    DURING A SURGERY, IT WAS REPORTED THE TORQUE LIMITING DRIVER (80-1008) WAS "FAULTY" AS THE DRIVER TIP SNAPPED OFF THREE (3) 1.5MM HEX DRIVER TIPS. THE SURGEON IMPLANTED A VA 2.3MM SCREW, AND THE FIRST 1.5MM DRIVER TIP SNAPPED. THE BROKEN DRIVER TIP WAS REMOVED, AND A SECOND 1.5MM DRIVER TIP WAS USED AND ALSO SNAPPED. A THIRD 1.5MM DRIVER TIP WAS USED AND ALSO SNAPPED. THE SURGERY WAS EVENTUALLY COMPLETED, AND THIS ISSUE PROLONGED THE SURGERY BY 5-10 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THIS REPORT IS RELATED TO REPORT NUMBERS 3025141-2023-00331, 3025141-2023-00332 AND 3025141-2023-00334.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691841 1.5MM HEX DRIVER TIP, LOCKING GROOVE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ACUMED, LLC 80-0728 568121

    Patients

    Seq Age Sex Outcome Treatment
    1 Female