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 reported has been verified and repaired.Performed service and repair functions.Reviewed service history.Replaced worn fingers on complete pressure adjusters with tip replacement kits to correct issue.Also replaced crack suction safety cover and damage guide line.The unit passed all diagnostic tests, functional tests, and is fully operational.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.
|