BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRA-CUT DISPOSABLE CRANIAL PERFORATOR

    MDR report key: 1372634 · Received April 15, 2009

    Report

    Report Number
    1372634
    Event Type
    Malfunction
    Date Received
    April 15, 2009
    Date of Event
    February 27, 2009
    Report Date
    April 15, 2009
    Manufacturer
    ACRA-CUT, INC.
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE DRILLING A BURR HOLE WITH THE DRILL, THE 14MM BURR BROKE OFF AT THE SHAFT ENTRY TO THE DRILL HANDLE. A NEW DRILL AND NEW 14 MM BURR WERE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRA-CUT DISPOSABLE CRANIAL PERFORATOR BLADE, CRANIAL HBF ACRA-CUT, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR