BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM CANN. QUICK RELEASE DRIVER TIP

    MDR report key: 17293343 · Received July 10, 2023

    Report

    Report Number
    3025141-2023-00354
    Event Type
    Injury
    Date Received
    July 10, 2023
    Date of Event
    June 15, 2023
    Report Date
    July 7, 2023
    Manufacturer
    ACUMED, LLC
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. THE RETURNED DRIVER WAS EXAMINED UNDER MAGNIFICATION. UNDER MAGNIFICATION, THE BATCH NUMBER FOR THE 1.5MM CANN. QUICK RELEASE DRIVER TIP (PART NUMBER HT-0915) WAS CONFIRMED AS 253190. A TORSIONAL FRACTURE PATTERN WAS IDENTIFIED AT THE HEX PORTION OF THE DRIVER. THE DRIVER TIP WAS MEASURED TO DETERMINE THE LOCATION OF FRACTURE. THE DRIVER MEASURED 3.433 INCHES, INDICATING THAT THE FRACTURE OCCURRED APPROXIMATELY 0.067 INCHES FROM THE END OF THE DRIVER TIP. A SMALL FRAGMENT OF THE DRIVER TIP WAS ALSO RETURNED. THERE WAS VISIBLE TWISTING OF THE HEX EDGES ON BOTH THE DRIVER TIP AND THE RETURNED FRAGMENT INDICATING SIGNIFICANT TWISTING PRIOR TO FRACTURE. A TORSIONAL FRACTURE PATTERN LIKELY INDICATES AN EXCESSIVE TWISTING LOAD ABOUT THE DRIVER'S CENTRAL AXIS. HEX TIP BREAKAGE MAY OCCUR WHEN EXCESSIVE FORCE IS APPLIED TO THE DRIVER DURING USE TO OVERCOME INCREASED RESISTANCE. HOWEVER, BASED ON THE INFORMATION RECEIVED AND DUE TO UNKNOWN SURGICAL CONDITIONS, THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A ROUTINE REMOVAL SURGERY, WHEN THE SURGEON TRIED TO REMOVE THE SCREWS (ACUTRAK2 MICRO SCREWS), THE DRIVER TIP WAS STRIPPED. MOREOVER, THE DRIVER TIP BROKE. THEY MANAGED TO REMOVE THE SCREWS BY CUTTING A LARGE PIECE OF BONE NEAR THE INSERTION SITE WITH A K-WIRE AND GRASPING THE BASE OF THE SCREW WITH A LOCKING HEMOSTATIC FORCEPS. IT WAS REPORTED THE AFFECTED AREA WAS HEAVILY SWOLLEN WITH A LOT OF BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2170814 1.5MM CANN. QUICK RELEASE DRIVER TIP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ACUMED, LLC HT-0915 253190

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male Other