BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYDRILL PERFORATOR

    MDR report key: 12040309 · Received June 22, 2021

    Report

    Report Number
    1625507-2021-00210
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Report Date
    June 22, 2021
    Manufacturer
    MICROMAR INDUSTRIA E COMERCIO LTDA
    Product Code
    HBF
    UDI-DI
    07898959543333
    PMA / PMN Number
    K141455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    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 1618/19 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 THE DEVICE WENT TOO FAR AND DIDN'T STOP AS IT SHOULD HAVE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938816 EASYDRILL PERFORATOR DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOU HBF MICROMAR INDUSTRIA E COMERCIO LTDA DM0010FAA 1618/19 07898959543333

    Patients

    Seq Age Sex Outcome Treatment
    1