BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIOS, TABLE BASE

    MDR report key: 21510791 · Received March 3, 2025

    Report

    Report Number
    2921578-2025-00004
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    February 26, 2025
    Report Date
    April 2, 2025
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION OBTAINED FROM INVESTIGATION, THE HOSPITAL DID NOT CORRECTLY SETUP THE TRACTION PULLEY ASSEMBLY FOR THE TRACTION ROPE TO PASS WITH AN ANGLE THROUGH THE PIVOT SHAFT OF THE HEAD-END COLUMN SO AS TO NOT RUB THE TRACTION ROPE AGAINST THE HOLE THUS LEADING TO SEVERING/BREAKAGE. THERE IS ALSO NO EVIDENCE IF THE HOSPITAL USED OR ATTEMPTED TO USE CERVICAL TRACTION VECTOR ADJUSTER TO ADJUST THE ANGLE AND PULL OF CERVICAL TRACTION AND MAINTAIN ALIGNMENT OF THE TRACTION ROPE WITH SKULL TONGS OR HEAD HALTER. THE IFU/OWNER'S MANUAL OF THE TABLE BASE AND THE TABLETOP DOES MENTION SUFFICENT INSTRUCTIONS PERTAINING TO THE USAGE AND SETUP OF TRACTION PULLEY ASSEMBLY, TRACTION ROPE AND CERVICAL VECTOR ADJUSTER DURING INTENDED SURGICAL PROCEDURES. THIS INCIDENT HAS THUS BEEN DEEMED AS USE ERROR AS THERE WAS A FAILURE TO FOLLOW MANUFACTURER'S INSTRUCTIONS FOR DEVICE USAGE AND RECOMMENDED BEST PRACTICES.

    Description of Event or Problem · 0

    DURING PATIENT USE THE TRACTION ROPE BROKE. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 0

    DURING PATIENT USE THE TRACTION ROPE BROKE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586161 TRIOS, TABLE BASE OPERATING TABLE JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 7803

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown