Aspen surgical received a report from the distributor indicated that a blade broke during a procedure at the end user.No adverse effect to the patient was noted.No sample or photographic evidence was available for evaluation.A manufacturing lot number was provided for review.Customer reported that the blade broke during the procedure and no injury occurred.The blade was retrieved successfully.A review of the device history record was completed.No non-conformance's related to the reported issue were identified.The most probable root cause could have been during the stamping or grinding process.Packaging process has established controls to mitigate broken or cracked blade condition, including a "medio" blade sensor that inspects 100% of packed pouches liner level prior to aluminum foil packaging.Also, excessive force applied by end user during surgery process could also cause blade condition.The following controls are in-place to mitigate "broken blade" condition at aspen surgical las piedras site: heat treatment in-process at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test.Heat treatment quality inspections at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test.Based on this information, no further action is required.
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