This mdr is being submitted as part of service and repair remediation activities associated with capa (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.The unit was received with missing plunger cap and 80# torque knob: the lock has both rotational and lateral movement also is hard to lock and a residue buildup is present.Upon disassembly repair it was noted that the index knob is cracked and the lock need new components to replace worn internal parts; general maintenance and cleaning 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.
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