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 was provided for review.End user indicated that post stab incision, one half of the broken blade section remained in the incision into the knee joint during a left knee meniscus tear procedure.The surgeon utilized a c-arm x-ray machine to locate the blade on x-ray and remove it.The procedure continued as planed following removal of the blade piece and no follow care was required.A review of the device history record could not be completed as no manufacturing lot number was provided for review.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.
|