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.No manufacturing lot number or sample was provided for review.End user indicated that during skin incision of a shoulder arthroscopy procedure, the blade broke into pieces in the patient.The surgeon was able to retrieve all pieces.No report of adverse patient consequences.The procedure was completed, the patient was discharged the same day and noted to be recovering.Due to no lot number provided, a review of the device history record could not be completed.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.
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