It was reported that handpiece and point probe wouldn't calibrate.Took point probe off and re-seeded it onto handpiece, and did that about 5 times.Loosened the handpiece tracker array and re-tightened it but didn't work, so then the 6mm guard on end of handpiece was checked, locked that back into place and tried recalibrating but that didn't work either.Turned machine off and rebooted it while pulling another tray for another point probe, handpiece and tracker array.Tried again once navio rebooted with same instruments and still didn't calibrate.Switched out the instruments with the extra tray and it still didn't calibrate.Tried moving point probe different ways on handpiece to see if that will help calibration but still nothing worked.Took all instruments off the field and went to a total knee arthroplasty.Tried calibration and got it to work after 2 tries.
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H10 h3, h6: the navio surgical system was used in treatment and case log files and screenshots were returned for evaluation.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 found similar reports and this issue will continue to be monitored.The navio surgical technique guide for use with stride unicondylar knee system was reviewed and it has information regarding calibration and proper detachment of handpiece from the calibration probe.Accordingly, product labeling has been ruled out as a cause of the complaint.This failure is captured in the navio risk profile.The navio surgical system logs was returned for evaluation and an initial visual/functional evaluation did not confirm the reported problem.The complainant indicated that after surgery the calibration was performed without an issue.During device evaluation of the handpiece tracker which was returned, was in working condition with no bends, or damage of any kind.The software log files only contained sampling errors.It is noted that the case was performed with spheres, and not flat markers.The reported issue likely occurred due to movement between handpiece and point probe during calibration.The root cause of this issue was determined to be no problem found.
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