The devices, used in treatment, was returned for evaluation.A visual inspection was performed and confirmed the stated failure.The metal tips of the drivers showed signs of rust.The devices were manufactured in 2014 and 2015.Upon review of the returned parts it was noted that the d-rad t7 capture driver hex bit is corroded while still packaged.Nothing noted in the dhr or internal operations that would indicate this issue to be caused internally.Our lab noted: the presence of rust in several sections of the devices.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A root cause could not be determined with the information provided.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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