It was reported that, during set up for a cori assisted tka surgery, a communication failure error occurred when they were attempting to run a drill diagnostics test.The procedure was finished with a smith and nephew back up device without delay.The patient was not harmed.
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Section h3, h6: the real intelligence cori, pn: rob10024, sn: sn (b)(6) used for treatment was not returned to the designated complaint unit for evaluation, and the cori log files and/or case files were not provided.Therefore visual and functional inspections and log/case file assessments could not be performed, and the reported problem could not be confirmed.The drill used in this case was returned for evaluation, where no visual or functional issues were identified.A possible contributing factor for the communication failure error could be an obstruction within the drill attachment, or an intermittent issue with the drill¿s exposure motor that prevents the carriage from moving to its intended position.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.Based on the investigation, no containment or corrective actions are recommended at this time.H6: health effect - clinical code.
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