BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS BLADE

    MDR report key: 11716178 · Received April 23, 2021

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    Report

    Report Number
    1045254-2021-00198
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 29, 2021
    Report Date
    July 19, 2021
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS FOUND THE MIDDLE ASSEMBLY WOULD ROTATE FREELY. THE INNER ASSEMBLY CUTTER ROTATED FREELY. THE BLADE SEATED INTO THE HANDPIECE WITH EASE. THE BLADE OSCILLATED IN THE LAB AND EXHIBITED A WOBBLE AND VIBRATION. THE INNER BLADE WAS REMOVED AND SPUN ON A FLAT RAISED SURFACE. THE HUB DID NOT APPEAR TO BE CONCENTRIC. H6: FDM B17, FDR C20, FDC D14 NO LONGER APPLY. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REPORTED THAT THE BLADE WOBBLED DURING SINUSITIS SURGERY. THERE WAS 5 MINUTE DELAY. THERE WAS NO PATIENT IMPACT. A NEW BLADE WAS OPENED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615720 XPS BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884380HR

    Patients

    Seq Age Sex Outcome Treatment
    1