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.Lock is stiff and hard to lock and unlock: unit received without pedi rocker arm or suit case.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances related to the reported failure.
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