BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRA-CUT

    MDR report key: 3766473 · Received March 19, 2014

    Report

    Report Number
    3766473
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 19, 2014
    Manufacturer
    ACRA-CUT, INC.
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THE CRANIAL ACRACUT PERFORATOR WAS RECENTLY INTRODUCED TO ADDRESS A PROBLEM WITH DRILL BITS "PLUNGING" (WHEN THE DRILL BIT DOESN'T STOP). THE RESIDENTS HAVE COMPLAINED OF SOME CHATTER FROM THE ACRACUT DRILL BIT, BUT HAVE EXPERIENCED EPISODES WHEN THE BIT DOES NOT GO ALL THE WAY THROUGH THE CRANIUM. THE OPERATING ROOM LEADERSHIP AND NEUROSURGERY DEPARTMENT QUALITY CHAIR HAS BEEN INFORMED AND THE PRODUCT THAT MALFUNCTIONED IS BEING LOOKED AT BY BIO-MED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165139 ACRA-CUT DRILL BIT CRANIAL PERFORATOR HBF ACRA-CUT, INC. * 8455

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR THE BONE (CRANIUM). A SECOND RESIDENT ALSO STATED| WHILE STARTING TO PERFORM A RIGHT CRANIOTOMY FOR| HEMATOMA IN THE OPERATING ROOM, THE PERFORATOR| MALFUNCTIONED X2. THE NEUROSURGERY RESIDENT STATED| THAT THE PERFORATOR STOPPED WHEN GOING THROUGH| THE SAME.