An investigation of the femoral cutting block, distal paddle, and microblock was performed.The cutting block was able to be assembled to the returned microblock without any issue.There were no issues observed during a fit check of all three mechanical instruments.No issues were observed with the distal paddle.No issues were observed with the microblock.No issues were observed with the femoral cutting block.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.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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