BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM QUICK RELEASE DRILL

    MDR report key: 23795672 · Received December 12, 2025

    Report

    Report Number
    3025141-2025-00734
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    November 6, 2025
    Report Date
    December 12, 2025
    Manufacturer
    ACUMED LLC
    Product Code
    HTW
    PMA / PMN Number
    K233311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 80-0318 DRILL (BATCH 489196) WAS RETURNED IN TWO PIECES: A LARGER MAIN BODY SEGMENT AND A SMALLER TIP SEGMENT. DRILL EXHIBITS A FRACTURE REGION WITH FRACTURE SURFACES SITTING OBLIQUE TO THE DEVICE AXIS. FRACTURE SURFACES ARE LIGHTLY TEXTURED. THE HELICAL FLUTES OF THE DRILL ADDITIONALLY EXHIBIT DAMAGE/DULLING ON THE TIPS OF THE DRILL FLUTES. THE HELICAL FLUTES OF THE DRILL ADDITIONALLY EXHIBIT DEFORMATION, WHERE THE CLOCKWISE (AS VIEWED FROM THE TIP END) SPIRAL OF THE FLUTES REVERSES INTO A COUNTERCLOCKWISE HELIX. LASTLY, THE FLUTED PORTION OF THE DRILL EXHIBITS AN OFF-AXIS BEND. NO DEFINITIVE CONCLUSIONS CAN BE MADE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: DURING SURGERY USING AN AL2 PLATE (70-0372-S :604287), THE DRILL WAS BROKEN. THE DRILL WAS ABLE TO BE EXTRACTED AND IS NOT LEFT BEHIND IN THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2759236 2.0MM QUICK RELEASE DRILL BIT, DRILL HTW ACUMED LLC 80-0318 489196

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown