If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the defect has been verified and repaired.The following activities were performed: performed service and repair functions.Reviewed service history.Attach box label, software upgrade form, and fms vue final testing.Replaced cpu board to correct issue.Also, performed software upgrade to the latest versions.Replaced springs on pressure arm housing (preventive maintenance) with tip replacement kit.The unit passed all diagnostic tests, functional tests, and is fully operational.Further a review into the depuy synthes mitek complaints system revealed no other 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 (b)(4) as required under mitek¿s corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
|