Aspen surgical received a report from the distributor indicating that bard-parker blades broke during a procedure.The incident occurred at the user facility.Sample was not available and no photographic evidence was available for evaluation.A manufacturing lot number was provided for review.End user indicated that during surgical bilateral foot procedures, two size 15 blades broke in the bilateral foot wounds.The surgeon successfully retrieved all broken pieces from both surgical foot wounds.Complete removal was verified via fluoroscopy.Patient tolerated well and no follow-up care was required.A review of the device history record indicated no non-conformance's related 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 during surgery process could also cause blade condition.The following controls are in-place to mitigate "broken blade" condition at aspen surgical (b)(4) 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.Device not available.
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