BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYDRILL PERFORATOR

    MDR report key: 10376638 · Received August 6, 2020

    Report

    Report Number
    1625507-2020-00116
    Event Type
    Injury
    Date Received
    August 6, 2020
    Date of Event
    January 16, 2020
    Report Date
    August 6, 2020
    Manufacturer
    MICROMAR INDUSTRIA E COMERCIO LTDA
    Product Code
    HBF
    UDI-DI
    07898959543333
    PMA / PMN Number
    K141455
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN. NO EVALUATION WAS PERFORMED, AS THE DEVICE WAS NOT RETURNED. THIS DM0010FAA EASYDRILL CRANIAL PERFORATOR WITH LOT NUMBER 1933/19 WAS MANUFACTURED BY MICROMAR. MULTIPLE WARNINGS ARE INCLUDED IN THE EASYDRILL CRANIAL PERFORATOR IFU MANUAL INCLUDING: IT IS ESSENTIAL TO KEEP THE DRILL PERPENDICULAR (90°) AT THE PREDETERMINED POINT OF THE SKULL TO BE DRILLED, AS AN EXCESSIVE DEVIATION FROM PERPENDICULARITY MAY CAUSE THE PRODUCT TO FAIL AND LEAD TO SERIOUS PATIENT INJURY. SELECT A DRILL BIT SUITABLE FOR THE BONE THICKNESS. THIS PREVENTS THE DRILL FROM TEARING THE BONE OR BRAIN TISSUE (SIMILAR EFFECT WHEN THE BIT IS NOT POSITIONED AT 90°). IF THE COMPONENTS OF THE EASYDRILL CRANIAL PERFORATOR BECOME LOOSE DURING TREPHINATION, DISCONTINUE USE. THE DRILL CAN CUTOR TEAR THE DURA MATER WHEN IT UNLOCKS. CHECK SOME CONDITIONS BEFORE PERFORMING THE PROCEDURE, SUCH AS THE EXISTENCE OF ADHERING DURA MATER OR OTHER ANOMALIES ADJACENT TO THE DRILLING SITE. WE WILL CONTINUE TO TRACK AND TREND THIS COMPLAINT TYPE. (B)(6). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE FOR A TUMOR RESECTION, THE PERFORATOR DID NOT STOP SPINNING WHILE CREATING THE INITIAL BUR HOLE. IT HAPPENED WHILE PASSING THROUGH THE SKULL THUS PLUNGING INTO THE TISSUE. IT WAS ALSO ADDED THAT THERE WAS A PROCEDURE DELAY TO CONTROL THE BLEEDING. THE REMAINING BUR HOLES WERE COMPLETED USING AN ACRA-CUT PERFORATOR. ON FOLLOW UP, NO FURTHER INFORMATION CAN BE PROVIDED REGARDING THE STATUS OF THE PATIENT POST-SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836754 EASYDRILL PERFORATOR DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED) HBF MICROMAR INDUSTRIA E COMERCIO LTDA DM0010FAA 1933/19 07898959543333

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other