A doctor reported experiencing a series of bent knife tips during surgery which leaves the knife blunt, therefore, creating cut resistance.Alternate knives had to be obtained in order to complete the procedures.There has been no patient impact.Additional information has been requested.
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No sample or lot number information 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 has been requested.(b)(4).
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