BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOR LEGEND EHS STYLUS

    MDR report key: 22373460 · Received July 1, 2025

    Report

    Report Number
    1625507-2025-01744
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    June 8, 2025
    Report Date
    August 26, 2025
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    UDI-DI
    00763000430894
    PMA / PMN Number
    K012456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS :EVALUATION DETERMINED THAT THE DEVICE WAS OVERHEATING, AND THE TEMPERATURE RISE WAS MEASURED TO BE 31°F. THE L IKELY CAUSE OF FAILURE COULD NOT BE DETERMINED. IT WAS NOTED ALSO THAT THE MOTOR BEARINGS WERE WORN, THE COLLET BEARINGS WERE WORN, AND THE COLLET LASER MARKINGS WERE FADING. 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: DEVICE RETURNED; EVALUATION ANTICIPATED BUT NOT YET BEGUN. B3:DATE OF EVENT NOTIFICATION. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING.NO PATIENT IMPACT REPORTED.ON FOLLOW UP, IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING.NO PATIENT IMPACT REPORTED.ON FOLLOW UP, IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193936 MOTOR LEGEND EHS STYLUS DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE HBE MDT POWERED SURGICAL SOLUTIONS EM200 00763000430894

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown