Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device was received at the service center and evaluated.The defect reported by the customer has been verified and repaired.This complaint is confirmed.Salt was found inside the pump; the unit was cleaned.The cpu board was found to be defective and was replaced.The repaired device passed all tests and is fully functional.The root cause is saline fluid getting into the pump which resulted in the cpu board failure.A review of the device history record indicated that this lot of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.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.(b)(4).
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