(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 sent to the service center for evaluation.Per service manual operational and diagnostic analysis confirmed reported issue (suction issue).Replaced worn fingers on complete pressure adjusters with tip replacement kits as identified in the investigation to address the reported issue, also replaced damage teflon spacers.The repair and testing of the unit was completed per the service manual, bringing the unit back to full functionality.The unit passed all functional tests and is fully operational.Based on the serial number this device is approximately 11 years old and could¿ve seen heavy use in the field.The device components could be worn from fair wear and tear.This serialized device was manufactured prior to kimball, therefore a dhr review cannot be performed since the original manufacturer no longer exists and the current manufacture can no longer make any process correction or corrective actions if needed.A review into the depuy mitek complaints system revealed five dissimilar complaints for this serialized device.These devices are frequently sent in for repair due to the nature of their use, and longevity in the field.At this point in time, no corrective action is required, and no further action is warranted.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).
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