Mazor X Robotic Guidance System

In July 2021, two dedicated impact assessments were discussed during a triage meeting for the service pack release of software version 5.0.1. the first assessment related to the potential for the robotic arm to move into the work volume area under certain conditions. specifically, after closing the "remove extender" warning message, if the user stops the surgical arm movement by using "send surgical arm - stop" when moving from AP (anterior posterior) to OBL (oblique) during registration, the surgical arm will move to the OBL location without regard to the work volume restrictions. If the shortest path is through the work volume, the arm will invade this area. While the motion velocity of the surgical arm is limited and the surgical arm stops moving if force is applied, movement into the work volume area is unintended behavior. The emergency stop button is not impacted by this issue and as identified in labeling can be used to stop the surgical arm movement at any stage during the procedure. To avoid this behavior altogether, the arm can be sent to a clear position after hitting "send surgical arm - stop" and before "send surgical arm - play". Medtronic has received one (1) customer complaint regarding this issue.  The second assessment identified a condition where loss of communication between the PC and the surgical arm may potentially go undetected. This could result in unexpected arm movement when sending the surgical arm to the previous arm location because the PC may potentially not identify the correct surgical arm location. the emergency stop button is not impacted by this issue and as identified in labeling can be used to stop the surgical arm movement at any stage during the procedure. the clinical support team can very if the actual arm position matches what is shown on the software screen. If there is a mismatch between the actual arm location and the visual on the screen, the user can perform a hard reset to the system to restore the communication between the PC and the surgical arm. the issue was identified internally during testing and there have been zero (0) customer complaints associated with this anomaly.

Recall start date: 2021-12-16