BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.8MM QUICK RELEASE DRILL

    MDR report key: 23123140 · Received September 23, 2025

    Report

    Report Number
    3025141-2025-00480
    Event Type
    Injury
    Date Received
    September 23, 2025
    Date of Event
    September 2, 2025
    Report Date
    October 24, 2025
    Manufacturer
    ACUMED, LLC
    Product Code
    LXH
    PMA / PMN Number
    K233311
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED DRILL WAS VISUALLY INSPECTED UNDER MAGNIFICATION. UNDER MAGNIFICATION THE BATCH NUMBER OF THE 2.8MM QUICK RELEASE DRILL (PN 80-0387) WAS CONFIRMED THE TIP OF THE DRILL IS BROKEN OFF, WITH A FRACTURE PLANE TRANSVERSE TO THE LONG AXIS OF THE DRILL. THE SURFACE IS LARGELY GRITTY AND DULL IN APPEARANCE, AND THE EDGES OF THE CUTTING FLUTES ARE DENTED, SLIGHTLY DEFORMED AND WORN. THE LENGTH WAS MEASURED USING MITUTOYO CALIPERS (GAGE ID # (B)(4), CALIBRATED 10/09/2025, CALIBRATION DUE 04/30/2026) TO APPROXIMATE THE LOCATION OF FRACTURE. THE DRILL MEASURED 6.0565" INDICATING THAT APPROXIMATELY .9435" HAD BROKEN OFF THE END OF THE DRILL. THE BROKEN FRAGMENT WAS NOT RETURNED. UNDER MAGNIFICATION THE FRACTURE PATTERN SHOW SIGNS OF SHEAR FORCE BREAK. THIS IS CONSISTENT WITH THE DRILL BEING ROTATED WITH ENOUGH TORQUE TO BE BROKEN. IT IS POSSIBLE THAT THE DRILL COULD HAVE BEEN STUCK IN A DRILL GUIDE IF IT WAS INSERTED OFF AXIS. HOWEVER, NO DEFINITIVE CONCLUSION COULD BE MADE.

    Additional Manufacturer Narrative · 0

    TO DATE, THE DEVICE HAS NOT RETURNED FOR EVALUATION, THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A FOLLOW UP REPORT IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN OPEN REDUCTION AND INTERNAL FIXATION USING THE CALCANIAL PLATE, THE DRILL WAS BROKEN. THE DRILL COULD NOT BE EXTRACTED AND REMAINED IN THE BODY. THERE WAS NO REPORTED DELAY AND IT WAS REPORTED THE PATIENT REMAINED STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218948 2.8MM QUICK RELEASE DRILL ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ACUMED, LLC 80-0387 423783

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other