BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRODEBRIDER BLADES AND BURS

    MDR report key: 14221827 · Received April 27, 2022

    Report

    Report Number
    1045254-2022-00216
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Date of Event
    February 24, 2022
    Report Date
    May 29, 2022
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: THE HANDPIECE HAD A BLADE STUCK INSIDE OF HOUSING. VISUALLY, THE INNER SHAFT WAS DISLODGED AND MISSING FROM THE INNER HUB. THE HUB SEAL WAS STILL IN PLACE BUT WAS WORN. THE HUB BUSHING WAS ROUGH AND WORN. THERE WAS DEFORMATION IN THE DISTAL OUTSIDE DIAMETER OF THE HUB WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THE OUTSIDE DIAMETER OF THE INNER HUB SHOULD BE 0.330 ± 0.002 INCHES AND MEASURED 0.329 INCHES IN THE UNDAMAGED AREA AND UP TO 0.349 INCHES IN THE DEFORMED AREA WHICH WAS OUT OF SPECIFICATION. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE BROKEN STATE OF THE DEVICE. CONCLUSION: IN THE RETURNED CONDITION, THERE WAS AN OUT OF SPECIFICATION CONDITION THAT WAS RELATED TO THE COMPLAINT (DUE TO PHYSICAL DAMAGE). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE DEVICE WAS NOT WORKING PROPERLY. THE PIECE INSIDE WAS LOOSE. EVENT FOUND POST-OP. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 0

    ON FOLLOW-UP, IT WAS REPORTED THAT THE END THAT CONNECTS TO THE HUB WAS BROKEN. THERE WERE NO FRAGMENTS/PIECES DETACHED FROM THE BROKEN DEVICE AND THEREFORE, NONE CAME IN CONTACT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478703 MICRODEBRIDER BLADES AND BURS BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. XOM UNK MICDEBBUR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown