It was reported that after a cori assisted surgery during "postop gap assessment" part of the surgery, it was found that the femur and tibia was shown subluxated on the screen, but actually the femur and tibia were not subluxated.Patient was not harmed beyond the problem reported.
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H3, h6; the real intelligence cori, part number rob10024, serial number (b)(6), used for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.The failure mode and associated risk have been anticipated within the risk file.As a result of the risk assessment the quality team has been notified for further investigation.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with selection of registration points.Based on the investigation, the need for a corrective action is not recommended or required at this time.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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