Model Number ROB10024 |
Device Problems
Intermittent Continuity (1121); Connection Problem (2900); Mechanics Altered (2984); Unintended Application Program Shut Down (4032)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/10/2022 |
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 a cori-assisted total knee arthroplasty, the following errors were displayed: robotic drill critical error, system timeout error, communication failure error.This happened with two separate drills.At first, the system did not recognize either drill when plugging into the console.A reboot was performed and a drill diagnostics test was run for both, in which the critical drill errors were received.The system was rebooted again and a new case was added; the console recognized one of the drills but then a system timeout error kept appearing during the unlock drill step of setup/calibration.Surgery was completed, after a delay of less than 30 min, with manual instrumentation.There was no harm to the patient.
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Event Description
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It was reported that, during a cori-assisted total knee arthroplasty, the following errors were displayed: robotic drill critical error, system timeout error, communication failure error.This happened with two separate drills.At first, the system did not recognize either drill when plugging into the console.A reboot was performed and a drill diagnostics test was run for both, in which the critical drill errors were received.The system was rebooted again and a new case was added; the console recognized one of the drills but then a system timeout error kept appearing during the unlock drill step of setup/calibration.Surgery was completed, after a delay of less than 30 min, with manual instrumentation.There was no harm to the patient.Upon investigation, it was confirmed that both real intelligence robotic drills presented defective exposure motors; one of them presented a damaged pin 9 (sn =(b)(6) and the other one had all pins damaged (sn = (b)(6).
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Manufacturer Narrative
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The ri robotic drill, part number rob10013, serial number (b)(6), used in treatment was returned for evaluation.A relationship between the reported events and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problems were confirmed.All kpc tests failed during drill diagnostics prior to a robotic drill critical error.Test case setup could not be completed due to a system time out error loop.Substituting the exposure motor with a test lab motor corrected the problem.An engineering review was completed.The reported problem was confirmed.The exposure motor encoder was tested and found to be unresponsive.The most likely cause of this event is a faulty exposure motor connection.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.A historical escalation event review was completed.The review determined that prior escalation actions are applicable to the scope of this complaint and further investigation into the reported failure is being conducted to determine if additional escalation actions are required.In the event of a system failure, refer to the recovery procedure guidelines in the real intelligence cori for knee arthroplasty user manual.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details from the us, it was reported that, during a cori-assisted total knee arthroplasty, several errors were displayed.Surgery was completed, after a delay of less than 30 min, with manual instrumentation.There was no harm to the patient.Further investigation into the reported failure is being conducted to determine if additional actions are required.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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Section h3, h6: the ri robotic drill, part number rob10013, serial number (b)(6), used in treatment was returned for evaluation.A relationship between the reported events and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problems were confirmed.All kpc tests failed during drill diagnostics prior to a robotic drill critical error.Test case setup could not be completed due to a system time out error loop.Substituting the exposure motor with a test lab motor corrected the problem.An engineering review was completed.The reported problem was confirmed.The exposure motor encoder was tested and found to be unresponsive.The most likely cause of this event is associated with a 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.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.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.In the event of a system failure, refer to the recovery procedure guidelines in the real intelligence cori for knee arthroplasty user manual.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.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.H6: component code, type of investigation, investigation findings and investigation conclusions.
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Search Alerts/Recalls
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