BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR - IPC® M5 AND M4 30K

    MDR report key: 19492397 · Received June 7, 2024

    Report

    Report Number
    1045254-2024-00866
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    May 13, 2024
    Report Date
    November 11, 2024
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    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

    IT WAS REPORTED THAT DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY, FIVE OF THESE BURS WERE BROKEN AFTER USING FOR A LITTLE WHILE. NO FRAGMENTS WERE DETACHED FROM THE BURS. THEY STARTED WOBBLING/ROTATING AROUND AFTER USING. THE BURS STARTED TO ROTATE AROUND IN THE SHAFT OF THE M5 AND HAD TO BE REPLACED WITH A NEW BUR EACH TIME. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2318804 XPS® BUR - IPC® M5 AND M4 30K BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884070RTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown