H3, h6: the navio handpiece, used in treatment, was not return for evaluation.The navio handpiece would not start during calibration, prior to a procedure on (b)(6) 2019.An initial visual/functional investigation was not performed.The complainant communicated that the handpiece would not be returned because it was tested and found to be working with no issues.It is possible that after handpiece calibration, when the user moved on to retraction, the handpiece did not move because the snap lock was already fully retracted.If the user was expecting to see some retraction, it could have been misunderstood as an issue.However, this cannot be confirmed nor verified.A device history record review was not performed since there was no part/serial/lot number provided and it could not be concluded if the device met the manufacturing specifications.A complaint history review found no similar reports, as the 1 complaint in the review is this complaint, and this issue will continue to be monitored.The navio surgical system for total knee arthroplasty user's manual released at the time of the complaint released at the time of the complaint provides instructions on troubleshooting homing/calibration issues.This failure is captured in the navio risk profile.The root cause of this issue was undetermined.
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