If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement the complaint device was received and evaluated.Visual observations reveal that all components on the returned sheath are intact and there are no loose or broken parts.The screws below the inflow/ outflow valves were disassembled to check for any wear that would cause this failure.It appears that on one valves, the threads are worn and corroded possibly from the repeated use & sterilization cycles.When assembled, the fixture is tight and allows the valves to move without loosening.The screws are able to hold the valves tightly in position without any discrepancies as reported in the complaint.We cannot confirm this complaint at this point.A batch record review has been conducted and our 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 mitek complaints system revealed no other complaints of any kind for this lot of devices released for distribution.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.(b)(4).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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