Section h10: the real intelligence cori used for treatment was not returned to the designated complaint unit for evaluation, therefore, visual and functional inspections could not be performed.Although the product was not returned the software files were downloaded from the device and provided for investigation.The naviosystem.Log provided for the case completed on 07-jun-2021, case id: (b)(4), confirmed the tibia bone model generation error.The most likely cause of the tibia bone model generation error is a known software bug associated with the bone mesh generation.Refer to the real intelligence cori for knee arthroplasty user manual for data point collection, including tibia free collection.If a collection error occurs, a message displays, reporting the specific error to the user, and providing instruction for solution.Most indications require clearing the message from the screen, by pressing ok, and performing the steps again to re-collect.As part of corrective actions, this issue has been corrected and released in cori-v1.4.3 software.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.Escalation actions applicable to the scope of the reported complaint have been identified, and it was determined that no further action is required at this time.This issue will be continuously monitored through complaint investigation and post market surveillance.Internal complaint reference number: (b)(4).
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