BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYDRILL PERFORATOR

    MDR report key: 20814364 · Received December 1, 2024

    Report

    Report Number
    1625507-2024-01139
    Event Type
    Malfunction
    Date Received
    December 1, 2024
    Date of Event
    November 5, 2024
    Report Date
    June 24, 2025
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBF
    UDI-DI
    07898959543609
    PMA / PMN Number
    K141455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6:CORRECTION :ANNEX D CODE UPDATED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS FOR DM0210FAA WITH LOT #1416/24: EVALUATION COULD NOT REPRODUCE THE REPORTED MALFUNCTION OF CONTINOUS TO RUN. ANNEX B AND C CODE UPDATED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H3:PRODUCT ANALYSIS: NO CONCLUSION CAN BE DRAWN. DEVICE WAS RETURNED AND THE EVALUATION ANTICIPATED BUT NOT YET BEGUN. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN THE PROCEDURE OF CRANIOTOMY THE DRILL DOESN'T MAKE CORRECT TURNS . IT STOPS FOR A WHILE THEN TURNS BACK ON. IT WAS REPORTED THAT INTERVENTION HAS BEEN PERFORMED. THE PROCEDURE WAS COMPLETED WITH THE BACKUP PRODUCT. UPON FOLLOWUP IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT. THERE WAS A DELAY FOR 30 MINUTES DURING THE PROCEDURE. NO INTERVENTION PERFORMED OR PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2619091 EASYDRILL PERFORATOR DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOU HBF MDT POWERED SURGICAL SOLUTIONS DM0210FAA 1416/24 07898959543609

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown