An investigation of returned navigation unit log file found the femoral axis registration numbers were beyond typical numbers.The user received the jig out of range error several times until the jig was re-pinned.The numbers indicate the jig was likely pinned too high or incorrectly, this is further supported by the fact the user selected an a/p offset of 1 which is the minimum amount.If the true a/p offset was a higher number, the output would have been closer to a nominal case.Root cause was unable to be determined for this complaint but since the behavior described is shown in the log file, the complaint can be confirmed.A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.Orthalign, inc.Will continue to monitor this issue and take action if alert limits are exceeded.This initial report is being filed after the due date as the initial submission was found to have not be received during an attempt to submit the follow-up report.At that time, the error message "error: initial report / prior supplement has not been received.The initial report is missing." alerted orthalign inc of the issue prompting the submission of this as an initial report.
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