ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.

The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the issue. An incorrect trajectory could result in serious injury or death if undetected during surgery.

On September 22, 2021, the firm, Zimmer Biomet, issued "URGENT MEDICAL DEVICE CORRECTION" letters to affected consignees. Customers were informed of steps that may result in the issue and that should be avoided: After the registration of the patient during the ROSA One 3.1 Brain application procedure, the issue may occur when the device shuts down either manually or unexpectedly. After reboot, if the trajectory is interrupted by deactivating the pedal, the device gives the user an option to Return to HOME , Clear the robotic arm , or Continue . If the user chooses to Clear the robotic arm , the device prompts the user to perform an empty device calibration. If the user performs this step and presses start, the issue will occur, which results in the device driving to an incorrect trajectory. Pending the implementation of a corrective action, Medtech S.A - Zimmer Biomet - advises that the actions detailed below to be taken without delay by all users of the ROSA One 3.1 Brain application device. Required actions by users to prevent incorrect instrument configuration (Workaround): If a shutdown occurs during guidance mode, any empty calibration window that would subsequently appear during the session should be closed by pressing UNDO. Customers were provided with a laminated warning label to attach to the robot. A Zimmer Biomet engineer will visit each customer site to implement a new software version to correct the issue once it is available. It is estimated that the updates will begin approximately in February 2022 and be completed by May 2022. If you have further questions or concerns, please contact your Zimmer Biomet representative or call the Product Surveillance Manager at [email protected].