It was reported that, during a cori-assisted tka surgery, a drill disconnect error message was displayed continuously (10 times).Troubleshooting steps were followed (pressed quit, disconnected handpiece, reloaded data) to solve the error case (b)(4).Additionally, the screen was turning off case (b)(4) and a bone model generation error was displayed, the model was lost case (b)(4).They recovered by rebooting.The procedure was completed with the same devices without significant delays (fewer than 30 minutes).The patient was not harmed.
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The real intelligence cori, pn: rob10024, sn:(b)(6) used for treatment was returned to the designated complaint unit for evaluation.A relationship between the reported event and the device was not confirmed.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was not confirmed.A case was run and the bone model generation was not lost at any point during testing.The console functioned as expected without any errors or unintended shut downs.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports, this issue will continue to be monitored.A capa, hhe/pra, field action review was completed.A review of prior escalation actions found related actions that are applicable to the scope of the reported complaint.The result of the review identified that the capa is still in the investigation phase.In addition, the capa owner has been notified.Although the reported problem was not confirmed a factor that may have contributed to the reported symptom may be associated with 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, the tibia bone model generation error has been corrected and released in cori-v1.4.3 software.No further containment or corrective action is required at this time.
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