BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYDRILL PERFORATOR

    MDR report key: 11660760 · Received April 13, 2021

    Report

    Report Number
    1625507-2021-00070
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    March 22, 2021
    Report Date
    April 13, 2021
    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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN. NO EVALUATION WAS PERFORMED, AS THE DEVICE WAS NOT RETURNED. IF THE DEVICE IS RETURNED IN THE FUTURE, PRODUCT ANALYSIS MAY BE PERFORMED. THIS DM0010FAA EASYDRILL CRANIAL PERFORATOR WITH LOT NUMBER 1628/19 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 CUT OR 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. 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, THE PERFORATOR DID NOT STOP AND DAMAGED THE DURA. IT WAS ALSO CONFIRMED UPON COMPLETION OF THE PROCEDURE, THAT THE BRAIN SURFACE WAS NOT INJURED. ON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS NO PROCEDURE DELAY, THERE WAS NO BACK-UP DEVICE USED, AND THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556062 EASYDRILL PERFORATOR DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED) HBF MICROMAR INDUSTRIA E COMERCIO LTDA DM0010FAA 1628/19 07898959543333

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other