BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® SYSTEM NAVIGATED BLADE

    MDR report key: 19057338 · Received April 8, 2024

    Report

    Report Number
    1045254-2024-00502
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    March 6, 2024
    Report Date
    June 14, 2024
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    UDI-DI
    00763000579272
    PMA / PMN Number
    K130608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: EXPIRATION DATE, LOT NUMBER AND UNIQUE IDENTIFIER (UDI) HAS BEEN UPDATED. ADDITIONAL CODES: PREVIOUSLY APPLIED CODE IMF F24 IS NO LONGER APPLICABLE.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

    H3: VISUALLY, THE INNER SHAFT WAS BROKEN 0.59 INCHES FROM THE DISTAL END OF THE INNER HUB WHEN RETURNED. THERE WAS CONTAMINATION ON THE OUTSIDE DIAMETER OF THE OUTER TUBE AND INSIDE DIAMETER OF THE INNER CUTTER TIP. THE OUTSIDE DIAMETER OF THE INNER CUTTER TIP SHALL BE 0.145 ± 0.001 INCHES AND THE ACTUAL MEASUREMENT WAS 0.146 INCHES WHICH WAS IN SPECIFICATION. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE BROKEN STATE OF THE DEVICE. A REVIEW OF THE GLOBAL COMPLAINT DATA SHOWED NO OTHER COMPLAINTS ABOUT THIS LOT NUMBER. IN THE RETURNED CONDITION, THERE WAS AN OUT OF SPECIFICATION CONDITION THAT WAS RELATED TO THE COMPLAINT. H6: PREVIOUSLY APPLIED CODES FDM B17, FDR C20 AND FDC D14 ARE NO LONGER APPLICABLE. ADDITIONAL CODES: PREVIOUSLY APPLIED CODE IMG G04041 IS NO LONGER APPLICABLE.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

    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 RECEIVED STATED THAT THE BROKEN PART REMAINED IN THE M4 HANDPIECE UNTIL TAKEN OUT. FRAGMENTS DID NOT FALL INTO PATIENT. THERE WAS A PROCEDURAL DELAY OF THIRTY MINUTES. THE BLADE WAS RUN AT A SPEED OF 5000 RPM. THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE CASE, ALL THE BLADES BROKE IN THE SAME PLACE MORE TOWARDS THE SHAFT. THE BROKEN PART REMAINED IN THE M4 HANDPIECE. THERE WAS NO KNOWN PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408274 XPS® SYSTEM NAVIGATED BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884380EM 0227880462 00763000579272

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown