BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR - HIGH SPEED CURVED

    MDR report key: 19517500 · Received June 12, 2024

    Report

    Report Number
    1045254-2024-00886
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    May 1, 2024
    Report Date
    July 9, 2024
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    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: VISUALLY, THE INNER SHAFT WAS BROKEN 0.44 INCHES FROM THE DISTAL END OF THE INNER HUB WHEN RETURNED. THERE WAS NO DAMAGE TO THE DISTAL TIP, BUT THERE WERE TRACES OF WEAR ON THE INNER AND OUTER HUB BUSHINGS. ADDITIONALLY, THERE WAS DEFORMATION IN THE DISTAL OUTSIDE DIAMETER OF THE INNER HUB. THE OUTSIDE DIAMETER OF THE INNER HUB SHALL BE 0.330 0.002 INCHES AND MEASURED 0.329 INCHES IN THE UNDAMAGED AREA AND UP TO 0.355 INCHES IN THE DEFORMED AREA WHICH WAS OUT OF SPECIFICATION. FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE BROKEN STATE OF THE DEVICE. IN THE RETURNED CONDITION, THERE WAS AN OUT OF SPECIFICATION CONDITION THAT WAS RELATED TO THE COMPLAINT (DUE TO PHYSICAL DAMAGE). H6: CODES ARE UPDATED. PREVIOUSLY APPLIED FDM B21, FDR C21, FDC D16 CODES NO LONGER APPLICABLE.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: ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. 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 INTRA-OP, THE BUR WAS STUCK IN M5 HANDPIECE. THERE WAS NO PATIENT IMPACT. ANALYSIS CONFIRMED THAT TIP OF BUR WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369673 XPS® BUR - HIGH SPEED CURVED BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884068HS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown