No sample has been received by manufacturing for evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.All knives are 100% inspected by trained operators using a minimum of 10x magnification during manufacturing.Any defects, such as damaged tips and cutting edges, are removed from the lot and scrapped.Sharpness testing is performed and monitored during the finishing process to ensure the sharpness of the product.Additional information was requested.(b)(4).
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