Aspen surgical received a report from the end user indicating that a blade broke while removing it from the handle.Incident occurred at the end user.No injury occurred.No sample or photographic evidence was available for evaluation.A manufacturing lot number was provided for review.Customer reported that the blade broke when removing from the handle.All pieces were retrieved and disposed of.A review of the device history record was completed.No non-conformance's were noted relating to the reported issue.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 could also cause blade to break.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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