BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YUNO 2 EU WITH AUTODRIVE

    MDR report key: 15493755 · Received September 27, 2022

    Report

    Report Number
    8010652-2022-00030
    Event Type
    Injury
    Date Received
    September 27, 2022
    Date of Event
    November 26, 2021
    Report Date
    September 27, 2022
    Manufacturer
    MAQUET GMBH
    Product Code
    FQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH 143302B0 YUNO 2 EU WITH AUTODRIVE. IT WAS STATED THAT THERE WAS A PROBLEM RELATED TO THE OPERATING TABLE YUNO 2. ON (B)(6) 2021, A FRACTURE OF THE FEMUR OCCURRED FOLLOWING A TOTAL HIP PROSTHESIS SURGERY. THE EXTENSION PLATE 143366AC "CARBON-FIBRE EXTENSION PLATE 3" WAS USED IN THE SURGERY. BASED ON INFORMATION PROVIDED BY SUBJECT MATTER EXPERT (SME) WHO WAS PRESENT AT THE OPERATION, THE PROBLEM WAS SOLVED BY THE CHANGED POSITIONING OF THE COUNTER TRACTION BAR IN THE "3-HOLE" CFK PLATE. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE 143302B0 YUNO 2 EU WITH AUTODRIVE MET ITS SPECIFICATION. THE PROVIDED INFORMATION INDICATES THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. WHEN THE EVENT OCCURRED, THE 143302B0 YUNO 2 EU WITH AUTODRIVE WAS DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. THERE WERE NO SIMILAR COMPLAINTS RELATED TO THIS ISSUE. COMPARING THE NUMBER OF CLAIMED DEVICES TO THE NUMBER OF SOLD DEVICES WORLDWIDE, WE ESTABLISHED THAT THE FAILURE RATIO IS VERY LOW. FOLLOWING EVALUATION BY THE SME WHO WAS PRESENT AT THE OPERATION, THE PLACEMENT OF THE COUNTER EXTENSION PLATE IN THE CENTRAL POSITION, CAUSES THE FEMUR TO RISE OR BLOCK WITH THE CORNER OF THE PLATE AND WHEN THE STEM IS INTRODUCED WEAKENS THE TROCHANTER MINOR. THIS INDICATES USER ERROR RELATED TO INCORRECT PLACEMENT OF THE COUNTER EXTENSION PLATE. THEREFORE, THE PRODUCT IN QUESTION IS NOT DEFECTIVE. THE USER WAS INFORMED ABOUT IMPROPER USE. IN THE IFU (IFU143302XYEN04, PAGE 87) THE USER IS INFORMED HOW TO CORRECTLY MOUNT EXTENSION PLATE. WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION WOULD HAVE BEEN FOLLOWED THE INCIDENT WOULD HAVE BEEN AVOIDED. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY ACTION AT THIS TIME.

    Description of Event or Problem · 0

    ON (B)(6) 2021 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES YUNO 2 (143302B0). THE FOLLOWING WAS REPORTED TO US. THERE WAS A PROBLEM RELATED TO THE OPERATING TABLE YUNO 2. ON (B)(6) 2021, A FRACTURE OF THE FEMUR OCCURRED FOLLOWING A TOTAL HIP PROSTHESIS SURGERY. THE EXTENSION PLATE 143366AC "CARBON-FIBRE EXTENSION PLATE 3" WAS USED IN THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2257458 YUNO 2 EU WITH AUTODRIVE TABLE, OPERATING-ROOM, AC-POWERED FQO MAQUET GMBH 143302B0

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other 143366AC CARBON-FIBRE EXTENSION PLATE 3