The company issued the urgent field safety notice due to increased software error #3 codes when a Mako system shutdown or restart is not performed before switching between total knee and total hip applications.
If the Mako system generates the software error, Stryker said there could be a loss or deterioration of robotic system function and delays in surgery to exit and reenter the application page, restart the Mako Arm software, obtain a replacement Mako robotic system or convert to manual surgery.
The company also said the potential harms are complications associated with extended surgery.
Stryker’s mitigation
Stryker said that a Mako system shutdown or restart prior to launching another application eliminates the occurrence of the software error. Restarting the Mako Arm software before the start of a case or after the occurrence of software error #3 also reduces the hazards and harms.
The company recommends that healthcare providers use the risk mitigation steps to prevent software error #3 or to clear software error #3 if it is generated by the Mako robotic system. It also requests that healthcare providers return customer response forms to acknowledge the mitigation.
The Mako system has been an important driver of Stryker’s growth in knee and hip replacement tech, with over 1 million procedures performed in more than 40 countries. Needham analysts recently upgraded their rating of SYK shares from “Neutral” to “Buy” ahead of the launch of Mako shoulder and spine applications expected this year.
