Investigation found that complaint/issue was associated with the microblock (402042) instead of the distal guide assembly (402043).Udi updated to align with microblock part.Updated contact to be (b)(6), updated 510(k) to align with kneealign 2 instead of orthalign plus as the complaint was with the instruments, not the navigation unit.New data: added event/evaluation codes according to current reporting standards.A review of the device history record (dhr) for microblock assembly, part # 402042, lot # t11112301z was conducted.There were no process deviations (pd) and no nonconforming material reports (ncmr) within the dhr.The device passed all manufacturing specifications prior to release, and it is concluded that the review of the dhr did not identify any issues that may have contributed to this complaint.Failure is attributed to normal wear and tear given that lot number of microblock indicates unit was manufactured in 2011; failure attributed to unit exceeding it's useful life of 250 uses.
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