BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR

    MDR report key: 20145603 · Received September 5, 2024

    Report

    Report Number
    9612501-2024-02218
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    August 10, 2024
    Report Date
    April 21, 2025
    Manufacturer
    MEDTRONIC DOMINICANA
    Product Code
    EQJ
    UDI-DI
    00763000036065
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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

    H3: PRODUCT ANALYSIS FURTHER FOUND, AFTER FOLLOWING THE STEPS IN THE IFU FOR LOADING THE BUR INTO THE HANDPIECE, THE BUR WAS SECURELY LOADED INTO THE HANDPIECE AND NO WOBBLING WAS OBSERVED WHILE RUNNING UP TO 12 ,000RPM. IN THE RETURNED CONDITION, THERE WAS NO OUT OF SPECIFICATION CONDITION THAT WAS RELATED TO THE COMPLAINT. H6: PREVIOUSLY APPLIED CODES FDR C070605 AND IMG G04112 ARE NO LONGER APPLICABLE. IMG G04041 IS APPLICABLE. 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

    H3: PRODUCT ANALYSIS OF THE DEVICE FOUND THAT VISUALLY, THE PACKAGING POUCH WAS OPENED ON 3 OF THE 4 SIDES AND THERE WAS NO DAMAGE TO THE PACKAGING TRAY. ADDITIONALLY, THERE WAS NO DAMAGE TO THE DISTAL DIAMOND GRIT TIP AND THE DEVICE WAS NOT BROKEN. UNDER MAGNIFICATION, THERE WERE STRIATIONS IN THE SHANK UPON RETURN. THE OVERALL LENGTH OF THE DEVICE SHALL BE 3.850 +0.015/-0.010 INCHES, AND THE ACTUAL MEASUREMENT WAS 3.86 INCHES WHICH WAS IN SPECIFICATION. THE OUTSIDE DIAMETER OF THE SLEEVE SHALL BE 0.062 ± 0.001 INCHES, AND THE ACTUAL MEASUREMENT WAS 0.062 INCHES WHICH WAS IN SPECIFICATION. FOR FURTHER ANALYSIS, THE OUTSIDE DIAMETER OF THE SHANK WAS 0.058 INCHES. FUNCTIONALLY, THE BUR SECURELY FIT INTO A HANDPIECE, BUT WHILE RUNNING IN FORWARD MODE EXCESSIVE WOBBLING AND GRINDING WERE OBSERVED. H6: PREVIOUSLY APPLIED CODES OF FDM B17, FDR C20 AND FDC D16 ARE NO LONGER APPLICABLE. PREVIOUSLY APPLIED ADDITIONAL CODE OF IMG G04041 IS NO LONGER APPLICABLE. 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

    H6: PREVIOUS ANALYSIS FINDING "FOR FURTHER ANALYSIS, THE OUTSIDE DIAMETER OF THE SHANK WAS 0.058 INCHES." IS NO APPLICABLE. 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 PRE-OP, THE SKEETER BURS WERE WOBBLING AFTER INSERTION. ALL THE FOUR BURS WERE TESTED WITH SAME HANDPIECE. THE PROCEDURE WAS COMPLETED USING OTHER BURS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2042868 XPS® BUR BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC DOMINICANA 3155646 0226257741 00763000036065

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown