US Food and Drug AdministrationUS Food and Drug Administration
The FDA issued a class 1 recall for Zimmer Biomet’s ROSA Brain device, citing a software issue that can drive the robotic arm to an incorrect position resulting in risks for the patient. Thus far, Zimmer Biomet, formally known as Medtech Innovative Surgical Technology, has received 5 complaints related to this issue, including 1 patient injury.

Neurosurgeons and assisted medical personnel had previously been using the ROSA Brain device in operating rooms to complete various types of neurosurgery, including those for epilepsy and treatment of movement disorders. The FDA reported issues In both ROSA Brain v3.0.0.0 (v3.0.0.16 software) and ROSA Brain v3.0.0.5 (v3.0.0.20 software, collectively referred to as v3.0 software), leading to the recall.

Notably, this issue does not appear to affect other ROSA robot-assisted systems for brain, spine, and knee procedures.

The device, according to Zimmer, acts as a “GPS” of sorts for the skull, assisting surgeons in a number of cranial interventions in surgical planning with “pre-operative data, precise location of the patient’s anatomy, and accurate positioning and handling of instruments.”

Likewise, during surgery the device may assist the surgeon with a variety of surgical interventions such as biopsies, electrode implantation for functional procedures (stimulation of the cerebral cortex, deep brain stimulation), open skull surgical procedures requiring a navigation device, endoscopic interventions, and other procedures.2

Zimmer Biomet issued an Urgent Medical Device Correction to customers on September 10, 2019, stating the issue with ROSA and how they should respond. They urged customers to refer to the Urgent Device Correction letter for instructions on working around the issue, as well as promising customers that a company engineer would be deployed at each customer site to implement software version 3.1 to correct the issue.

No long-term adverse events were reported from the problem at the time. The issue resulted in a sequence workflow which can trigger a discrepancy between the initial skin marking on the skull and trajectory of the instrument being used.

“In all cases, the issue was detected visually and/or through software prompts detected by the user and there have been no long-term adverse patient effects,” the company stated in its September release.3

Although no deaths were reported, the FDA did identify the recall as class 1, which is the most serious type of recall. There have been 86 devices recalled in the US, and products were distributed from April 8, 2016 to March 19, 2019.

The company stated that it “is dedicated to patient safety, and quality excellence is an integral aspect of our commitment to the patients and surgeons who rely on our products every day. We stand behind our products and we will reconfigure all of the Rosa Brain 3.0 units that are on the market today in a comprehensive and timely manner to ensure quality, safety and efficacy.”

The full list of affected product codes can be viewed by clicking here.
REFERENCES
1. Zimmer Biomet Recalls ROSA Brain 3.0 Robotic Surgery System Due to Software Issue that Incorrectly Positions the Robotic Arm [press release]. Silver Springs, MD: FDA; Published November 7, 2019. fda.gov/medical-devices/medical-device-recalls/zimmer-biomet-recalls-rosa-brain-30-robotic-surgery-system-due-software-issue-incorrectly-positions. November 8, 2019.
2. Rosa Brain: Advantages of the Device. Medtech Innovative Surgical Technology website. medtech.fr/en/rosa-brain. Accessed November 8, 2019.
3. Zimmer Biomet Statement on ROSA Brain 3.0 Field Action [press release]. Warsaw, IN: Zimmer Biomet. Published September 13, 2019. investor.zimmerbiomet.com/news-and-events/news/2019/09-13-2019. Accessed November 7, 2019.