Zimmer Biomet—ROSA Brain 3.0 Surgical Systems: Instrument Holder May Be Sent on a Trajectory That Is Not within the Intended Target
September 18, 2019 | Risk Management News
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In a September 10, 2019, Urgent Medical Device Correction letter submitted by an ECRI Institute member hospital, Zimmer Biomet states that it has received reports in which the above ROSA Brain 3.0 systems' instrument holder was sent on a trajectory that was not within the intended target. The robot arm is intended to position the instrument holder on the selected trajectory so that rigid neurosurgical instruments (e.g., drill bits, screwdrivers, cannulae) are inserted through the adapter to perform the intended surgical procedure. Zimmer Biomet also states that while the incorrect trajectory was detected in all reports received to date (e.g., the robot arm is at an unusual distance from the patient's head, the instrument is not at the correct position), if the problem is not corrected, the associated device may be placed incorrectly (e.g., anchor bolt). Failure of the device to move to the correct trajectory, if not identified by surgical staff, could result in surgical delay, serious injury, brain cognitive injury, or death. Zimmer Biomet further states that after the registration of the patient in the ROSA Brain 3.0 device, the problem may occur only in guidance mode (e.g., when the robot arm is on trajectory) when the user selects the optical distance sensor and sends the robot arm on each entry point and then selects the instrument holder. In this scenario, the use of the "Undo" button in the tool installation panel will cause the problem because of a software anomaly. For further details regarding the sequence of events that...