BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT

    MDR report key: 25085864 · Received May 4, 2026

    Report

    Report Number
    MW5187683
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 28, 2026
    Manufacturer
    ACRA CUT, INC.
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ACRA-CUT DRILL PERFORATOR BIT WAS USED IN A PROCEDURE AND IT DID NOT ENGAGE THE CLUTCH MECHANISM WHICH CAUSED A DURAL TEAR. THE PERFORATOR BIT WAS A (B)(6) PRODUCT. THE PRODUCTS WERE EVALUATED WITH BIOMEDICAL ENGINEERING AFTER THE INCIDENT. IT WAS BELIEVED THAT THE MEDTRONIC PRODUCTS FUNCTIONED AS INTENDED AND THE ISSUE SEEMS TO BE RELATED TO THE (B)(6) (ARCA-CUT) PERFORATOR BIT. IT WAS CONFIRMED THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCTS. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494358 DRILL BIT DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED) HBF ACRA CUT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown