Aspen surgical received a report from the distributor indicating that item number 371115 bard-parker blade was found broken in its packaging.No injury/death reported.The incident occurred at the user facility.A manufacturing lot number was provided for review.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 could cause blade breakage.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.No sample was available and no additional information was provided.Based on this information, no further action is required.Device not available.
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