BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDAS REX LEGEND

    MDR report key: 21372166 · Received February 13, 2025

    Report

    Report Number
    1625507-2025-00259
    Event Type
    Malfunction
    Date Received
    February 13, 2025
    Date of Event
    August 31, 2022
    Report Date
    February 13, 2025
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    PMA / PMN Number
    K020069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: EVALUATION DETERMINED OVERHEATING. THE DEVICE WAS TESTED AND THE TEMPERATURE WAS MEASURED TO BE 109°F. THE LIKELY CAUSE 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 WAS REPORTED. ON FOLLOW-UP IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125620 MIDAS REX LEGEND MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS AA10DK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown