Aspen surgical received a report indicating that a bard-parker blade broke while in use during a procedure.The incident occurred at the user facility.A manufacturing lot number was provided for review.End user indicated that the blade broke inside the knee of the patient during a knee arthroscopy procedure which included synovitis of right post total knee.Blade broke at the time the surgeon was making his punctures with the blade and required intervention to retrieve it.Once the blade broke, the surgeon used a long grasper to retrieve the broken piece without opening the knee.Retrieval of the piece was successful and the procedure continued as intended.No adverse outcome to the patient.A review of the device history record was completed and no non-conformance's related to the reported issue were identified.The most probable root cause could have been machine related 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 the end user during surgery process could cause blade breakage.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.No sample was available for return.Based on this information, no further action is required.Device not returned.
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