Visual analysis was performed on the returned device which identified the support wire was separated.The reported kink was confirmed.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 other incidents.The investigation determined that the kink likely occurred during use.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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