BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRODEBRIDER BLADES AND BURS

    MDR report key: 19257639 · Received May 7, 2024

    Report

    Report Number
    1045254-2024-00680
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    March 25, 2024
    Report Date
    June 25, 2024
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS FOUND THAT VISUALLY, THE INNER SHAFT WAS DISLODGED AND NOT RETURNED WITH THE INNER HUB. THERE WAS DEFORMATION IN THE DISTAL OUTSIDE DIAMETER OF THE 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 0.363 INCHES IN THE DEFORMED AREA WHICH WAS OUT OF SPECIFICATION. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE BROKEN STATE OF THE DEVICE. 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: CODE UPDATED. PREVIOUSLY APPLIED CODE FDC D16 IS NO LONGER APPLICABLE.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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE M5 HANDPIECE REQUIRES REPAIR WITH NO OTHER COMMENTS PROVIDED. THERE WAS NO KNOWN PATIENT IMPACT. AS PER THE SERVICE REPORT OF M5 HANDPIECE, IT WAS CONFIRMED THAT M5 HANDPIECE ARRIVED WITH HALF OF THE BLADE STUCK AND BROKEN INSIDE THE HOUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669611 MICRODEBRIDER BLADES AND BURS BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. XOM UNK M-BUR-BLD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown