(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event - estimate.A visual inspection was performed on the returned device.A kink and shaft separation were noted during return analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the noted shaft separation.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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