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.Reported event: switched to straight saw blade after distal and posterior champher cuts were made and could not pass saw checkpoint.Attempted to reregistered 2 times and got registration error of.5 and.6 respectively.Exited out of software and tried again with the same result.Changed out handpiece, registered and everything passed and easily able to get through registration and straight saw blade cuts.Product evaluation and results: the product was not evaluated as the product was unavailable for inspection.Product history review: review of the product history records indicate 25 devices were manufactured under lot no k082e and accepted into final stock on 08/10/2016.No non-conformances were identified during inspection.Complaint history review: a review of complaints related to p/n 209063, prodex lot k082e shows no additional complaint(s) related to the failure in this investigation.Conclusions: the alleged failure mode could not be confirmed as the product was not available for inspection.No additional investigation or specific actions are required.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated that nc 1414517 and capa 1450904 are associated with the failure mode reported in this event.H3 other text : device not returned.
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