No sample has been rec'd by mfg for eval.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when add'l reportable info becomes available.All knives are 100% inspected by trained operators using a minimum of 10x magnification during mfg.Any defects, such as damaged tips and cutting edges, are removed from the lot and scrapped.Sharpness testing is performed and monitored during the finished process to ensure the sharpness of the prod.Add'l info has been requested, but is not anticipated.(b)(4).
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