BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRODEBRIDER BLADES AND BURS

    MDR report key: 19283371 · Received May 10, 2024

    Report

    Report Number
    1045254-2024-00692
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    March 8, 2024
    Report Date
    June 10, 2024
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE SERVICE REPORT CONFIRMED THE COMPLAINT AND NOTED THAT THERE WAS A FULL BUR STUCK IN THE COLLET WITH SHAVER HEAD BENT AND BROKEN. VISUALLY, THE INNER HUB WAS BROKEN/DISLODGED FROM THE OUTER ASSEMBLY. THE SHAFT (PART OF INNER HUB) WAS BROKEN 0.420 INCHES FROM THE DISTAL END OF THE INNER HUB TO THE BROKEN POINT. THE DISTAL END OF THE INNER HUB WAS DEFORMED (OUTSIDE DIAMETER). THE OUTSIDE DIAMETER OF THE INNER HUB SHALL MEASURE 0.330 ± 0.002 INCHES AND MEASURED 0.330 INCHES IN UNDAMAGED AREA AND 0.351 INCH IN DEFORMED AREA WHICH WAS OUT OF SPECIFICATION. THERE WAS NO DAMAGE NOTED ON THE OUTER TUBE OR THE OUTER HUB. HOWEVER, THE IRRIGATION PORT WAS DAMAGED, AND THE SPIRAL WRAP WAS BENT. THERE WAS ALSO INDENTATION ON THE PORTION OF THE INNER SHAFT THAT WAS STUCK INSIDE THE OUTER TUBE. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE BROKEN STATE OF THE DEVICE. BASED ON THE ANALYSIS, THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING CRITERION. H6: FDM B21, FDR C21, 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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT POST-OP, THE BUR WAS STUCK IN M5 HANDPIECE. THE ANALYSIS FOUND THAT THE BUR HEAD WAS BENT AND BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982700 MICRODEBRIDER BLADES AND BURS BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. XOM UNK MICDEBBUR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown