BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDAS REX MR8

    MDR report key: 21487809 · Received February 28, 2025

    Report

    Report Number
    1625507-2025-00554
    Event Type
    Malfunction
    Date Received
    February 28, 2025
    Date of Event
    May 15, 2023
    Report Date
    February 28, 2025
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    PMA / PMN Number
    K183515
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: EVALUATION COULD NOT REPRODUCE THE REPORTED MALFUNCTION AS THE TEMPERATURE WAS WITHIN SPECIFICATION AT 91.5°F. IT WAS ALSO NOTED OIL LEAK FROM HOSE EXHAUST. 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 REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661447 MIDAS REX MR8 MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS PM800-R

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown