Model Number ROB10013 |
Device Problems
Computer Software Problem (1112); Intermittent Continuity (1121); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/07/2022 |
Event Type
Injury
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Event Description
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It was reported that, during the distal burring process in a cori assisted tka surgery, a system time out alert to reinitialize the robotic drill was received.The error was cleared and when trying to burr again, the same error was received multiple times.They backed out of the case, unplugged the drill, restarted the system and same error was received.They tried to add more points to the femur, but a grayed out "next" button on the tibia twin peg selection and movement screen was received.The software was not frozen, as it was possible to go back to previous screens however it could not pass that screen.The procedure was completed with manual instrumentation without significatn delays.The patient was not harmed beyond the reported problem.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Manufacturer Narrative
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Section h3, h6: the real intelligence robotic drill, rob10013, serial number (b)(6) used for treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.An attempt to perform a case led to a system time out error and then a flickering checkmark on the hardware connection screen.The drill was disassembled and one of the wires going into the exposure motor wire cap was found to be broken.The most likely cause of this event is a broken wire caused by repeated stresses in a mechanically tight environment.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.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.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.Per complaint details from the us, it was reported that, during the distal burring process in a cori assisted tka surgery, a system time out alert to reinitialize the robotic drill was received.The error was cleared and when trying to burr again, the same error was received multiple times.The software was not frozen, as it was possible to go back to previous screens however it could not pass that screen.The procedure was completed with manual instrumentation without significant delays.The patient was not harmed beyond the reported problem.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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H11.Corrected codes in h6.
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Manufacturer Narrative
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H3, h6: the real intelligence robotic drill, rob10013, serial number (b)(6), used for treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.An attempt to perform a case led to a system time out error and then a flickering checkmark on the hardware connection screen.The drill was disassembled and one of the wires going into the exposure motor wire cap was found to be broken.The most likely cause of this event is a broken wire caused by repeated stresses in a mechanically tight environment.Another factor 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 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.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.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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