Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.3, h.6, h.10 and h.11 based on the results of investigatio n.Reported event: it was reported that the disk on the back of the adapter broke off and will not thread on.Product evaluation and results: visual inspection visual inspection confirms failed locking mechanism.There is oxidation and discoloratio n on the 202870 slide assembly, 202862 ball retainer.The 202866 knob can be unthreaded from the device.The 206966 reamer barrell has fractures/cr acks at the degree markers.See attachment s for images of the instrument.Dimensiona l inspection dimensiona l inspection was not completed as visual inspection clearly shows the failure of the device.Functional inspection functional inspection was not completed as visual inspection clearly shows the failure of the device.Material analysis material analysis was completed as part of the root cause investigatio n of capa 1450905 product history review: review of the product history records indicate 45 devices were manufactur ed under lot no 19170418 and accepted into final stock on 9/21/2018 with no reported discrepanci es.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 206967, lot number 19170418 shows 11 additional complaints related to the failure in this investigatio n.The complaints are pr: (b)(4).Conclusions : the failure is confirmed via visual inspection.No additional investigatio n or specific actions are required.If additional information is received then the complaint will be reopened.Corrective action/prev entive action: a review of stryker¿s nc/capa database indicated there have been an nc and capa associated with the product and failure mode reported in this event.This is nc 1414603 & capa 1450905.
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