Becker's Spine Review

34 DEVICES & IMPLANTS Zimmer Biomet recalls surgical robot By Alan Condon Z immer Biomet has recalled its Rosa One 3.1 brain application because of a soware error that could lead to the misplacement of instruments during neuro- surgical procedures. Rosa One comprises a mounted touch screen and a robotic arm designed to assist neuro- surgeons position medical instruments or implants during surgery. Examples of tools or instruments that can be attached to the robotic arm include endoscopes, biopsy nee- dles, stimulation or recording electrodes. The software issue could, for example, af- fect techniques that direct surgical tools using coordinates provided by medical im- aging to reach a specific part of the brain. If this occurs, it could cause adverse events such as stroke, severe injury, disability or death, according to the FDA, which identi- fied this as a Class I recall, the most serious type of recall. As of Oct. 29, three complaints have been filed about the issue. One of the complaints was submitted aer the robot inaccurate- ly placed an electrode on the brain during a procedure. No patient injuries or deaths have been re- ported, the company said. In a statement provided to Becker's Spine Re- view, Zimmer Biomet said it has "notified us- ers of the Rosa One 3.1 brain application of a soware upgrade to address the anomaly." While the soware upgrade is being imple- mented, the company said it "will work with surgeon users to ensure that there is no dis- ruption to their ability to safely perform pro- cedures on their patients." On Sept. 22, Zimmer Biomet issued an "ur- gent medical device correction" that de- scribed when the issue may occur and pro- vided steps for hospital staff and surgeons to follow to avoid it. According to the medtech company, the so- ware issue may occur when the system shuts down either manually or unexpectedly aer registration of the patient. Aer reboot, if the trajectory is interrupted by the deactivating 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 asks the user to per- form 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. Corrective updates to the system are expect- ed to be ready for installation by February, with all updates completed by May, Zimmer Biomet said. Since December 2019, the Rosa One Brain 3.1 application has been installed in the company's robots and has been used to perform about 3,600 brain surgeries. e FDA said that 119 devices have been recalled in the U.S. n Medtronic appoints new head of spine, cranial business By Alan Condon H arry "Skip" Kiil has been appointed president of Medtronic's cranial and spinal technologies operating unit, effective Jan. 4. For the past three years, Mr. Kiil has served as president of glob- al orthopedics at Smith+Nephew, where he was responsible for the company's reconstructive arthroplasty, robotics, trauma and extremities businesses. Prior to Smith+Nephew, he was executive vice president and president of global commercial operations at NuVasive and also served as surgical head of Novartis' Alcon eye care division for Europe, the Middle East, Africa, and Russia, where he led the commercial transformation of the surgical business across de- veloped and emerging growth markets. Additionally, over a 12-year period at Stryker, Mr. Kiil held sever- al leadership roles, including vice president and general manag- er for Europe and general manager for Japan. In his new role, he is responsible for driving innovation and de- livering therapies to global markets more effectively as well as cultivating a strong culture within the cranial and spinal technol- ogies unit. n Wireless implants planned for spinal fusion By Carly Behm O ne devicemaker's recent seed funding round could help bring wireless implants to spine surgery, IoT World Today reported Oct. 28. Intelligent Implants raised $9 million in seed fund- ing, provided in part by startup-building firm EIC Accelerator, and the devicemaker plans to com- mercialize a wireless implant for spinal fusion treat- ments. The implant, called Smart Fuse, incorporates a regular implant connected to wireless antennae for controlling electrodes that graft bone tissue into the body. Patients would use a spinal corset to secure the im- plant. Clinical trials are expected to start in 2023. Wireless implants aren't new to the orthopedic space. In October, New York City-based Hospital for Special Surgery implanted a wireless knee device for remote monitoring. n

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