BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDAS REX LEGEND

    MDR report key: 21392211 · Received February 18, 2025

    Report

    Report Number
    1625507-2025-00317
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    May 15, 2023
    Report Date
    February 17, 2025
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    UDI-DI
    00613994418852
    PMA / PMN Number
    K020069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 96.4°F. 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 WAS INITIATED FOR THE DEVICE WITH THE REPORT OF OVERHEATING AND NOISY. IT WAS REPORTED THAT THERE WAS NO PATIENT INVO LVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1490512 MIDAS REX LEGEND MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS AA15 00613994418852

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown