(b)(4).This report is being filed from the (b)(4) complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.The batch review 3475214 showed that the devices were conformed to in process and finished goods specifications when released to stock the 16 nov.2010.Expiration date: 2013-10 (according to retained labels).No nc was opened.Ri was opened relating to replacement of mitek hvac motor according to ot with no link with this complaint.Evaluation statement: the complaint device is not being returned, therefore is unavailable for a physical evaluation.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed with an unrelated out of tolerance (ot) to the reported 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 of any kind for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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