BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRODEBRIDER BLADES AND BURS

    MDR report key: 19630787 · Received June 28, 2024

    Report

    Report Number
    1045254-2024-00961
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    May 13, 2024
    Report Date
    July 23, 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

    DURING ANALYSIS OF THE HANDPIECE, IT WAS FOUND THAT THE BUR WAS NOT INTACT AND WHOLE. H3: ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE 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.

    Additional Manufacturer Narrative · 0

    THE SERVICE REPORT NOTED THAT THE HANDPIECE HAD A BLADE (BUR) STUCK INSIDE HOUSING ALSO WHEEL LOCK STUCK; BUR WAS REMOVED. VISUALLY, THE SPIRAL WRAP/INNER SHAFT WAS BROKEN 3.59 INCHES FROM THE DISTAL END OF THE INNER HUB WHEN RETURNED. THERE WERE INDENTIONS AND SCRATCHES ON THE OUTSIDE DIAMETER OF THE SHAFT THAT WERE CONSISTENT WITH TOOL MARKS. ADDITIONALLY, 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 0.365 INCHES IN THE DEFORMED AREA WHICH WAS OUT OF SPECIFICATION. THERE WERE TRACES OF WEAR IN THE HUB BUSHING. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE BROKEN STATE OF THE DEVICE. H6: FDM B21, FDR C21, IMG G04041 AND FDC D16 CODES NO LONGER APPLY. 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 POST OP THE DRILL BIT STUCK IN M5 HANDPIECE AND COULD NOT BE REMOVED. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2191938 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