BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRA

    MDR report key: 297238 · Received September 22, 2000

    Report

    Report Number
    297238
    Event Type
    Malfunction
    Date Received
    September 22, 2000
    Date of Event
    September 19, 2000
    Report Date
    September 19, 2000
    Manufacturer
    ACRA-CUT, INC
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WHILE USING STRYKER DRILL WITH 14MM PERFORATOR TIP, THE TIP BROKE WHEN DRILLING INTO THE SKULL. THE PERFORATOR TIP SPUN OFF OUT OF CONTROL, HITTING THE PT. THE PT SUSTAINED A LEFT ORBITAL WALL CHIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRA DISPOSABLE CRANIAL PERFORATOR HBF ACRA-CUT, INC 200-271 DGR-O 3457

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other