If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the unit was evaluated and the reason for return could not be duplicated.Unit will be sent to long term hold.The repair of the unit will not be completed at this time because there is no need for it in the pool due to excess units in the pool at this time.A review into the depuy synthes mitek complaints system revealed two dissimilar complaints for this device's serial number.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes 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.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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