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 investigation.Product identification: the returned product was confirmed to be a shell impaction platform, p/n 206270, l/n 45030116 and rma 263628.Inspection: visual inspection confirmed that the product's housing was broken in half where the button, pin and housing interface.Refer to attachment.Product history: review of the device history records indicate 103 devices were manufactured and accepted into final stock on 03/31/2016 for lot 45030116.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 206270, lot number 45030116 shows zero number of complaints related to the failure in this investigation.Nc/capa history review: a review of stryker¿s nc/capa database indicated there have been zero ncs or capas associated with the product and failure mode reported in this event.Conclusion: visual inspection confirmed that the product's housing was broken in half where the button, pin and housing interface.Part investigation confirms reported issue.
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