BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COUPLER II, MAIN ASSEMBLY

    MDR report key: 7266216 · Received February 13, 2018

    Report

    Report Number
    2921578-2018-00003
    Event Type
    Malfunction
    Date Received
    February 13, 2018
    Date of Event
    February 3, 2018
    Report Date
    April 20, 2018
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO DETERMINE ROOT CAUSE DUE TO PRODUCT NOT RETURNED FOR EVALUATION. FURTHER DISCUSSION REVEALED THAT THE SCREWS DID NOT BREAK DURING PATIENT POSITIONING. MOST LIKELY CAUSE OF WHY THE YELLOW SCREW WAS FOUND BROKEN COULD BE DUE TO THE UNIT BEING DROPPED OR MISHANDLED. THE OWNER'S MANUAL ADVISES THE USERS TO INSPECT THE DEVICE BEFORE EACH USE.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 20/18 COUPLER II WAS CONNECTED TO MIZUHO/OSI 5803 TABLE WITH SPINE FRAME. COUPLER II WAS CONNECTED TO THE MAYFIELD ALUMINUM SKULL CLAMP UTILIZING THE MIZUHO/OSI COUPLER II P/N 5873 AND ADAPTER P/N 5873-30. WHILE LOCKING THE ADAPTER TO THE COUPLER II WITH PATIENT POSITIONED IN THE MAYFIELD SKULL CLAMP, THE LARGE YELLOW SCREW CONNECTOR BROKE.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2018 COUPLER II WAS CONNECTED TO MIZUHO/OSI 5803 TABLE WITH SPINE FRAME. COUPLER II WAS CONNECTED TO THE MAYFIELD ALUMINUM SKULL CLAMP UTILIZING THE MIZUHO/OSI COUPLER II P/N 5873 AND ADAPTER P/N 5873-30. WHILE LOCKING THE ADAPTER TO THE COUPLER II WITH PATIENT POSITIONED IN THE MAYFIELD SKULL CLAMP, THE LARGE YELLOW SCREW CONNECTOR BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109194 COUPLER II, MAIN ASSEMBLY TABLE ACCESSORIES JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 5873

    Patients

    Seq Age Sex Outcome Treatment
    1 Other