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 not provided for review.Customer reported reported that the tip of the blade that was in the pack broke off in the patients shoulder during an arthroscopy at the beginning of the case.The piece of blade was retrieved and there was no injury to the patient.The blade was inspected and in one piece during set up.The blade and piece were placed in the sharps container and disposed.A review of the device history record could not be completed with no manufacturing lot number provided.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 additional actions required.Device not available.
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