Aspen surgical received a report from the end user indicating that a bard-parker blade broke while in use during a procedure.
The incident occurred at the user facility.
No sample or photographic evidence was available for evaluation.
No manufacturing lot number was provided for review.
Bard-parker blade broke off in the patients shoulder.
While making an incision in the patients skin during a shoulder procedure for an arthroscopy scope, the blade broke and required retrieval.
All pieces were retrieved successfully.
Patient is doing well.
A review of the device history record could not be completed.
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 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.
Based on this information, no additional actions required.
Device not returned.
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