Aspen surgical received a report from the distributor indicating that a bard-parker blade broke while in use during a procedure.The incident occurred at the user facility.No sample and no photographic evidence were provided for evaluation.Manufacturing lot number was available for review.Per the report received, the procedure was a knee arthroscopy.The surgeon made an incision and then afterwards, the scrub tech noticed the tip of the blade had broken off.An x-ray by mini c-arm was used to confirm if any metal was left in the patient's knee.No metal was seen on the x-ray.No patient identifiers were provided.No further follow-up was required.A review of the device history record indicated no non-conformance's related to the reported issue.Due to no sample and no photographic evidence, the condition of the blade could not be confirmed.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.A sample and photographic evidence were not provided.However, if a sample is returned and if any additional relevant information is identified, the additional relevant information will be submitted in a supplemental report.Based on this information, no further action is required.
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