BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRIS

    MDR report key: 17270863 · Received July 6, 2023

    Report

    Report Number
    9611102-2023-00041
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    June 8, 2023
    Report Date
    July 6, 2023
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXAMINATION IN THE SPECIALIST DEPARTMENT REVEALED THAT THE INSTRUMENT HAS RUN DRY PROXIMALLY, WHICH IS EVIDENT FROM THE DISTAL RUN-IN MARKS. THE MILLING CUTTER ITSELF OTHERWISE SHOWS NORMAL SIGNS OF USE. THE CAUSE OF THE FAULT IS THEREFORE ATTRIBUTED TO A HANDLING/OPERATING ERROR BY THE CUSTOMER. FROM OUR EXPERIENCE, SUCH BEHAVIOR USUALLY OCCURS WHEN THE MILLING CUTTER HAS BEEN OPERATED WITHOUT COOLING OR WITH INSUFFICIENT COOLING (DRY RUNNING), COUPLED WITH INCREASED CONTACT PRESSURE. CLEAR SIGNS OF USE CAN BE SEEN ON THE INNER PART, WHICH INDICATE DRY RUNNING, OR NO OR TOO LITTLE SUCTION (INCORRECT USE). THE DIAMOND BURR ROUND Ø 4MM, PART ID 899751404, ORIGINATES FROM THE ORDER PRODUCTION ORDER 2004202301 OF THE SUPPLIER 2543 EBERLE AND WAS POSTED TO THE NEW GOODS WAREHOUSE ON 27/APR/2023. APPARENTLY, NO DEVIATION WAS FOUND DURING THE INCOMING INSPECTION AND THE SUPPLIER ASSURED THAT THE PRODUCTS WERE MANUFACTURED ACCORDING TO THE AGREEMENTS. THE DELIVERY TO THE CUSTOMER FROM THIS BATCH, TOOK PLACE ON 08/MAY/2023. IN ORDER TO AVOID SUCH DAMAGES, THE CORRESPONDING INSTRUCTIONS FOR USE GA-B223 AND GA-A238-US / EN / 2020-12 V6.0 / PK20-0352, CHAPTER 5 "APPLICATIONS", CONTAIN CORRESPONDING INSTRUCTIONS FOR SUFFICIENT COOLING OF THE TOOL. IN CHAPTER 4.2 "FUNCTIONAL CHECK" THERE IS A NOTE THAT THE TOOLS MUST BE OPERATED IN LIQUID AND NOT DRY (COOLING OF THE HEAT GENERATED BY MECHANICAL FRICTION). IN OUR RISK ANALYSIS E5-4 R05, MANUFACTURING-RELATED, HANDLING-RELATED AND DESIGN-RELATED HAZARDS WITH REGARD TO A FUNCTIONAL IMPAIRMENT AS WELL AS RISKS DUE TO AN UNUSABLE PRODUCT WITH THE CORRESPONDING EXTENT OF DAMAGE AND THE ASSUMED PROBABILITY OF OCCURRENCE WERE CONSIDERED AND ASSESSED WITH AN ACCEPTABLE RISK.

    Description of Event or Problem · 0

    A USER FACILITY HAS INFORMED RICHARD WOLF GMBH AN ISSUE REGARDING A DIAMOND BURR ROUND Ø 4MM, PART ID: 899751404, SERIAL (B)(6). ACCORDING TO THE RECEIVED INFORMATION, "BURNT DURING USE. NO RISK TO THE PATIENT". ADDITIONALLY, THIS CASE WAS REPORTED BY THE CUSTOMER TO THE FRENCH NATIONAL AGENCY FOR THE SAFETY OF MEDICINES AND HEALTH PRODUCTS (ANSM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014867 VERTEBRIS DIAMOND BURR ROUND Ø 4MM HWE RICHARD WOLF GMBH 899751404 2004202301

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown