BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BLADE

    MDR report key: 19245996 · Received May 6, 2024

    Report

    Report Number
    1045254-2024-00658
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    February 26, 2024
    Report Date
    November 29, 2024
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    UDI-DI
    00681490613279
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF THE BUR FOUND THAT VISUALLY, THERE WAS CONTAMINATION ON THE OUTSIDE DIAMETER OF THE OUTER TUBE. THERE WAS NO EXTERNAL DAMAGE IN THE CONSTRUCTION OF THE DEVICE. THERE WAS NO DAMAGE TO THE DISTAL DIAMOND GRIT TIP AND NO LOOSE COMPONENTS. FUNCTIONALLY, THE INNER ASSEMBLY SPUN FREELY BY HAND WITH NO BINDING. THE BUR FIT SECURELY INTO A HANDPIECE, BUT WHILE RUNNING IN FORWARD MODE UP TO 6000RPM, EXCESSIVE WOBBLING AND A GRINDING NOISE OCCURRED. FOR FURTHER ANALYSIS, AN X-RAY WAS PERFORMED TO OBSERVE THE INTERNAL COMPONENTS OF THE DEVICE AND NO DEFECTS WERE OBSERVED. 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 THE OPERATION, THE BUR HAD POOR POLISHING EFFECT WHICH COULD NOT BE POLISHED AND WAS NOT CUTTING THE TISSUE. THE BUR GRINDING FAILED. AFTER REPLACING WITH THE NEW BUR, THE OPERATION COULD BE NORMAL. THERE PROCEDURE WAS COMPLETED BY BACKUP PRODUCT AND THERE WAS A DELAY OF 5 MINUTES. THERE WAS NO PATIENT INJURY. ANALYSIS OF THE DEVICE CONFIRMED THAT THE BUR HAD EXCESSIVE WOBBLING WHEN OPERATED AT 6000 RPM IN FORWARD MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662436 XPS® BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1882969 0220009964 00681490613279

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose