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 rough threads on the post bolt preventing the unit from properly attaching to the rail.The unit also has a bent handle on the post clamp subassembly allowing the clamp to rotate while in the locked position.General maintenance needed.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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