(b)(4).The device was manufactured april 7, 2015 - april 8, 2015.The device was received for evaluation.Visual inspection on the returned unit via the naked eye noted a line approximately 10.15 mm in length located on the stressmember.Examination of the line under the microscope showed the line was actually molded within the material of the stressmember and does not affect the device.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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