Aspen surgical received a report from the distributor indicating that a blade broke near the handle.Incident occurred at the end user.No injury occurred.No sample was available for evaluation.Photographic evidence and a manufacturing lot number was provided for review.Customer reported that the blade broke in three pieces near the handle during a procedure.The pieces laid on the patient and all pieces were retrieved and disposed of.There was no patient harm.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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