This mdr is being submitted as part of service and repair remediation activities associated with (b)(4).The device was returned to the manufacturer for service and repair.The unit was cleaned per protocol.It was noted upon inspection that the returned unit did not meet all specific functional tests.Unit received with the left and right pawls are cracked.Unit needed starburst threads to be re-tapped.Unit was received with a metal free extension arm.General maintenance and cleaning were required.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances related to the reported failure.Nit received with the left and right pawls are cracked.Unit needs starburst threads need to be retapped: unit was received a metal free extension arm; general maintenance and cleaning required.
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