H10:the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device's threads were found to have metal debris within it, rendering the device inoperative.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.According to the inspection drawing, final inspection includes verifying parts are free of burrs, steps or sharp edges, as well as clean and with uniform finish.A contribution of the device to the reported event could be corroborated as the device had debris present in the threads.A potential probable cause could be but is not limited to a manufacturing deficiency.Based on this investigation, the need for corrective action is not indicated.This issue was evaluated through our internal quality process and determined to be isolated at this time.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.Internal complaint reference number: (b)(4).
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