BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYDRILL CRANIAL PERFORATOR 14MM

    MDR report key: 19999656 · Received August 19, 2024

    Report

    Report Number
    19999656
    Event Type
    Malfunction
    Date Received
    August 19, 2024
    Date of Event
    June 12, 2024
    Report Date
    August 5, 2024
    Manufacturer
    MEDTRONIC
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AFTER USING THE MIDAS REX DRILL WITH THE BURR HOLE PERFORATOR, THE PERFORATOR SNAPPED AT THE BASE WHILE SURGICAL TECH [REDACTED NAME] AND SURGEON [REDACTED NAME] ATTEMPTED TO REMOVE IT FROM THE MIDAS. PERFORATOR AND MIDAS WORKED WITH NO ISSUES WHILE IT HAD BEEN IN USE, AND NO HARM WAS DELIVERED TO THE PATIENT. BOTH PIECES OF PERFORATOR TAKEN OFF SURGICAL FIELD AND PLACED BACK IN ITS ORIGINAL CONTAINER, WHICH WAS THEN PLACED IN A BIOHAZARD BAG. GIVEN TO [REDACTED NAME] CHARGE RN SO THAT IT CAN BE DELIVERED TO [REDACTED NAME] IN THE AM. PERFORATOR INFORMATION AS FOLLOWS: MEDTRONIC EASYDRILL CRANIAL PERFORATOR 14 MM, REF DM0010FAA, LOT # 0461/24, EXP. [REDACTED DATE]. MANUFACTURER RESPONSE FOR MIDAS REX DRILL EASYDRILL CRANIAL PERFORATOR 14 MM, MIDAS REX DRILL EASYDRILL CRANIAL PERFORATOR 14 MM (PER SITE REPORTER) [REDACTED DATE] [REDACTED NAME] WILL BE INFORMING THE MFG AND ASKING IF THEY WANT IT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2394570 EASYDRILL CRANIAL PERFORATOR 14MM DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC 0461/24

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose