If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate the complaint devices were received and evaluated.The dimensional inspection confirmed the drill bit was out of specification and the failure was attributed to human error during manufacturing.Nc has been initiated at mitek to capture supplier capa for this issue.Appropriate measures and corrective actions were implemented to mitigate this failure.A batch record review has been conducted and the results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints reported from the same facility for this lot of devices that were released to distribution.However, depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.(b)(6)-incomplete.Associated medwatches: 1221934-2018-51833, 1221934-2018-51834.This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
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