The complaint device is not being returned, therefore unavailable for a physical evaluation.Nineteen unused devices from the same lot were sent back.Five devices were visually and functionally tested out of the returned samples.Visual observation of all of the five devices, revealed no anomalies with the blades, or the sleeves surface.The first sample was connected to the fms vue pump and activated in saline solution.No metal shavings/particles were observed in the saline solution.The device was inspected again after the functional test, and no anomalies were found.The test was repeated for the other four samples, and they passed the visual and functional testing.The reported complaint cannot be confirmed.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed no other complaint of any type for this lot of devices that were released to distribution.A white paper was performed previously on this failure and the result indicated that the amount of shedding for this product is acceptable.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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