Model Number ROB10013 |
Device Problem
Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/05/2022 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that, during the femur milling stage of a cori assisted surgery, the error "the robotic drill has been deactivated" came on the screen.They reconnect and resume case but it did not work.The kpc testing also failed.As no backup drill was available, the procedure was completed with manual instrumentation without significant delays.The patient was not harmed beyond the reported problem.
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Manufacturer Narrative
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The real intelligence robotic drill, part number rob10013, serial number (b)(6) intended for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.Refer to the real intelligence cori for knee arthroplasty user manual, section setting up a cori knee procedure: setting up the instruments, connecting the robotic drill for proper set up and handling.The failure mode and associated risk have been anticipated within the risk file.As a result of the risk assessment the quality team has been notified for further investigation.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with an exposure motor encoder failure.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
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Manufacturer Narrative
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The real intelligence robotic drill, part number rob10013, serial number (b)(6), intended for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.Refer to the real intelligence cori for knee arthroplasty user manual, section setting up a cori knee procedure: setting up the instruments, connecting the robotic drill for proper set up and handling.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A historical review concluded that the lot, serial number or part number reported in this event is related to a corrective/preventive action already implemented.Although the reported problem was not confirmed through a visual or functional evaluation, factors that may have contributed to the reported symptom may be associated with an intermittent failure of the drill exposure motor due to the thermo-mechanical stress induced within the motor at the encoder and electrical noise on the console error status inputs to the drill exposure motor encoder.Continuous improvements have been made to the cori robotic drill and manufacturing processes to reduce drill disconnection error messages.These improvements consisted of: 1.A hardware update to the cori console to reduce noise on the internal electronics.2.An update to the cori system¿s software and firmware to improve the user experience when error messages are displayed, and 3.A hardware update to the cori drill to reduce mechanical stress on drill exposure the motor.The first two improvements are fully deployed.The third improvement is being deployed for new orders and as drills are returned for routine servicing.Also, smith+nephew is voluntarily performing a recall/field notification for the cori real intelligence robotic drill.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
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Search Alerts/Recalls
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