Model Number ROB10013 |
Device Problems
Connection Problem (2900); 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 10/19/2022 |
Event Type
malfunction
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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 set-up for a cori-assisted tka procedure, they received a communication failure error during calibration.The system was rebooted along and ran a drill diagnostic test.Upon initial plug of the drill a robotic drill critical error was received.The procedure was finished with a smith and nephew back up device.As this happened before surgery, there was not patient involvement.
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Manufacturer Narrative
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The cori, real intelligence robotic drill, part number rob10013, (b)(6), intended for use in treatment was returned for evaluation.A relationship between the reported event and the device could not be established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed, and the reported problem was not confirmed, no communication failures or errors were received.Multiple cases and calibrations were completed without error.Multiple kpc tests were also completed without error.The drill was taken apart for further investigation and the drill¿s exposure motor was checked and was found to be functioning properly.The drill is operating as intended.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with a loose connection.A review of manufacturing records indicates the software 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.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, 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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H3, h6: the cori, real intelligence robotic drill, part number rob10013, (b)(6) intended for use in treatment was returned for evaluation.A relationship between the reported event and the device could not be established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed, and the reported problem was not confirmed, no communication failures or errors were received.Multiple cases and calibrations were completed without error.Multiple kpc tests were also completed without error.The drill was taken apart for further investigation and the drill¿s exposure motor was checked and was found to be functioning properly.The drill is operating as intended.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.A review of manufacturing records indicates the software 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.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.Additional information: h9.
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Search Alerts/Recalls
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