BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE CRANIAL PERFORATOR W/HUDSON END, 14/11 MMR

    MDR report key: 859201 · Received May 25, 2007

    Report

    Report Number
    MW5002093
    Event Type
    Malfunction
    Date Received
    May 25, 2007
    Date of Event
    May 14, 2007
    Report Date
    May 25, 2007
    Manufacturer
    ACRA CUT, INC
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN ACRA CUT DISPOSABLE CRANIAL PERFORATOR FAILED TO "AUTO STOP" ONCE THROUGH THE CRANIAL BONE. THE LOCATION OF THE HOLE WAS RIGHT FRONTAL, JUST ANTERIOR TO THE CORONAL SUTURE - NORMAL BONE THICKNESS. THE SURGEON DID NOT NOTICE ANY BONE PAD IN THE BOTTOM OF THE HOLE. THIS WAS THE 3RD OR 4TH HOLE DRILLED WITH THE SAME PERFORATOR. IT HAD WORKED CORRECTLY ON THE PREVIOUS HOLES DRILLED. HE SAID HE THOUGHT IT WAS TAKING LONGER THAN THE OTHER HOLES, THEN IT PLUNGED THROUGH THE DURA AND INTO THE HEMATOMA. THE SURGEON STATED THAT HE FELT HE WAS VERY LUCKY THAT THE HEMATOMA WAS THERE TO PREVENT DAMAGE TO THE BRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE CRANIAL PERFORATOR W/HUDSON END, 14/11 MMR NONE HBF ACRA CUT, INC 200-271 DGR-0 6050

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other