Rosa One Brain

2021: Withdrawal of defective systems

On October 29, 2021, it was reported that Zimmer Biomet recalls the defective robot neurosurgeons Rosa One 3.1 Brain Application for robot-assisted neurosurgical procedures, this review was assigned to class I. In total, three complaints were filed about the device problem, with no deaths or injuries recorded.

As of September 22, 2021, Zimmer Biomet sent an urgent recall of medical equipment for this platform as a result of a software (software) error. The affected devices, and in total there were 119 in the United States, were distributed between December 1, 2019 and August 31, 2021. The company withdrew the product due to an error in the software, which can lead to incorrect placement of instruments during stereotactic neurosurgical procedures, which can lead to adverse events, including stroke, serious injuries, severe disability or death.

Zimmer Biomet recalls defective neurosurgeon robots

Zimmer Biomet developed the Rosa One 3.1 Brain Application to help neurosurgeons position medical instruments or implants during surgery. The device includes a robotic arm and a touch screen mounted on a stand, and various medical instruments or devices can be attached to the end of the robotic arm, for example, biopsy needles, stimulating or recording electrodes, endoscopes, this is all based on the type of procedure. A previous version of the robotic platform faced similar problems when in September 2019 a software failure in Rosa Brain 3.0 devices led to a warning of the device. No long-term adverse events have been reported in connection with this problem, as a consistent workflow may cause a mismatch between the original skull skin markings and the tool trajectory.

Zimmer Biomet focuses on patient safety, and product quality is an integral aspect of our commitment to patients and surgeons who rely on our products daily. We stand for our products and will implement updated brain software for Rosa One 3.1 devices on the market in a comprehensive and timely manner to ensure quality, safety and efficiency, "said President and Chief Executive Officer Brian Hanson.

According to a representative of Zimmer Biomet, Rosa Spine, Rosa Total Knee, Rosa Partial Knee and Rosa Hip application systems are not affected by software anomalies, since the problem is characteristic only of the Rosa One 3.1 Brain application system. A company representative noted that the company had notified users of the anomaly software update and, prior to the completion of the update, the users had been given instructions to follow to resolve the anomaly. While the update is being implemented, Zimmer Biomet will work with surgeon users to avoid compromising their ability to conduct procedures safely. The company also independently informed the Food and Drug Administration (FDA) of the need to update the device software.^[1]

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