BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDAS REX MR8

    MDR report key: 21476915 · Received February 27, 2025

    Report

    Report Number
    1625507-2025-00536
    Event Type
    Malfunction
    Date Received
    February 27, 2025
    Date of Event
    April 19, 2023
    Report Date
    February 27, 2025
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBC
    PMA / PMN Number
    K183515
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: EVALUATION DETERMINED THAT THE DEVICE WAS OVERHEATING AND THE TEMPERATURE WAS MEASURED TO BE 120.1 DEGREES FAH RENHEIT. THE LIKELY CA USE OF FAILURE COULD NOT BE DETERMINED. THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW THROUGH CAPA 624392. 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

    REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699283 MIDAS REX MR8 MOTOR, DRILL, ELECTRIC HBC MDT POWERED SURGICAL SOLUTIONS EM800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown