H10 h3, h6: the device was used in treatment.The software version was not recorded, but dhr review shows that all navio software versions released to the field have been validated.A complaint history review identified prior similar events, this issue will continue to be monitored.The risk assessment released at the time of the complaint was reviewed and it notes the intended use, indication for use, and design assumptions of the navio system.The instruction for use (pn 500095 rev c) was reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.We could not confirm if there was a relationship established between the reported event and the device.This is part of a clinical retrospective study.Patient files showed that the surgeon checked that the severity was "moderate" and "serious".The event expectation was "unanticipated" and the actions taken were "physical/physio therapy", "medication therapy", and "surgery/procedure".The outcome is "recovering/resolving" and it says that it was "possibly" related to navio.It was likely that the arthrofibrosis could have been cause by lack of physical therapy.Discussion with medical affairs confirmed that arthrofibrosis can be typically tied to lack of physical therapy and we will continue to monitor this issue as the patient is enrolled in a clinical study.The investigation concluded there was no fault in the product, therefore it performed within the expected parameters.
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