BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BLADE

    MDR report key: 23023658 · Received September 11, 2025

    Report

    Report Number
    1045254-2025-02123
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    August 14, 2025
    Report Date
    October 6, 2025
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    UDI-DI
    00613994779182
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: ADDITIONAL INFORMATION HAS BEEN UPDATED. H3: PRODUCT ANALYSIS FOUND THAT THE DEVICE AND AN OPEN POUCH WERE RETURNED IN A RESEALABLE BAG. THE POUCH WAS OPEN FROM 3 OF 4 SIDES WHEN RETURNED. THERE WERE TRACES OF CONTAMINATION OBSERVED AT THE DISTAL END OF THE OUTER TUBE. IT WAS ALSO OBSERVED THAT THE SIDES OF THE DISTAL END OF THE INNER HUB WERE UNEVEN. THE INNER ASSEMBLY SPUN BY HAND WITH NO BINDING SOUND OBSERVED. THE DEVICE WAS LOADED INTO A HANDPIECE AND RAN IN OSCILLATING MODE UP TO 7 ,500RPM. DURING THE FUNCTIONAL TESTING THERE WAS AN EXCESSIVE WOBBLING OBSERVED. FOR FURTHER ANALYSIS, THE INNER ASSEMBLY WAS PULLED OUT OF THE OUTER ASSEMBLY, AND IT WAS OBSERVED THAT THE AREA OF THE INNER SHAFT LOCATED NEAR THE DISTAL END OF THE INNER HUB WAS BENT. THE DEVICE FAILED FUNCTIONAL TESTING DUE TO DEFECTIVE CONDITION UPON RETURN AND THE INABILITY TO ROTATE PROPERLY. THE COMPLAINT WAS CONFIRMED, DUE TO AN OUT OF SPECIFICATION CONDITION. H6: CODES B01, C070601, C070605, D1102 AND G04112 HAS BEEN UPDATED. THE PREVIOUSLY UPDATED CODES B17, C20 AND D16 WERE NO LONGER APPLICABLE.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

    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

    ADDITIONAL INFORMATION STATED THAT THE "WOBBLING" ISSUE WAS ISOLATED TO THE ORIGINAL BLADE; THE MICRODEBRIDER WORKED PROPERLY WITH A NEW BLADE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SET UP THE BLADE WOBBLED WHEN ACTIVATED, SEEMS INSECURE WITH THE MICRODEBRIDER HANDLE. THE HANDPIECE WAS THE COMPONENT THAT WAS VIBRATING AND CAUSED THE BLADE TO WOBBLE. THE VIBRATING DEVICE WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER BLADE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2233550 XPS® BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884380HR 0229147517 00613994779182

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown