Model Number ROB10024 |
Device Problems
Application Program Problem: Parameter Calculation Error (1449); 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 03/24/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that during a cori assisted surgery, when they were changing the plan after burring the distal femur, they moved to bur all of the tibia.They began to bur the tibia and an "internal error" popped up and said "application quit unexpectedly." they were able to quit out of the case, go back in, recalibrate the drill.The procedure was completed, with a non-significant delay, using the same device.Patient was not harmed beyond the problem reported.
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Manufacturer Narrative
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Internal complaint reference number: (b)(4).
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Event Description
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It was reported that during a cori assisted surgery, when they were changing the plan after burring the distal femur (because the surgeon felt the joint was too tight in extension, therefore they resected 1-2 more mm from the distal femur), they moved to bur all of the tibia.They began to bur the tibia and an "internal error" popped up and said "application quit unexpectedly." they were able to quit out of the case, go back in, recalibrate the drill.The procedure was completed, with a non-significant delay, using the same device.Patient was not harmed beyond the problem reported.
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Manufacturer Narrative
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H3, h6: the real intelligence cori, pn: rob10024, sn:(b)(6) used for treatment was not returned to the designated complaint unit for evaluation, therefore visual and functional inspections could not be performed.The software files were downloaded from the device and provided for investigation.The application log file (navio.Log) confirmed the intraop exited upon transitioning to ¿tibia bone removal,¿ confirming that the intraop likely crashed, and displayed the internal error message to the user.An internal error message is a result of an intraop crash.However, the log files (naviosystem.Log, xsession.Log, and/or coredump) needed for further investigation of the intraop crash were not provided for review.The most likely cause of the internal error is an occurrence of a known software defect that is under investigation.Refer to appendix d: recovery procedure guidelines in the real intelligence¿ cori¿ for knee arthroplasty user¿s manual.In the event of a system failure, cori has a built-in auto-recovery mechanism.If the failure occurs during the procedure, cori returns to the startup screens outside of the application.Cori prompts with the choice whether to resume the operation.Selecting yes returns to a specified checkpoint within the procedure, depending on when the failure occurred.If the failure occurs outside of the application, cori returns to the beginning of the startup sequence.A failure can consist of, but is not limited to, a system software crash, unrecoverable hardware failure, handpiece failure with no backup available, tracker failure or loss of contact with bone that is unrecoverable, etc.This situation is captured in the risk assessment released at the time of the complaint.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports.A review of prior escalation actions was performed and found no actions that are applicable to the scope of the reported complaint.This issue will be continuously monitored through complaint investigation and post market surveillance.
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Search Alerts/Recalls
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