Aspen surgical received a report indicating that a bard-parker blade detached while in use during a procedure.The incident occurred at the user facility.No manufacturing lot number or sample were provided for review.End user indicated that following a left shoulder arthroscopy, the surgical blade was retained in the patient's left shoulder for several days post discharge.The patient experienced post op discomfort and was evaluated in the emergency room and discharged.Several days later, patient was seen by the surgeon for post op visit where x-rays were obtained and noted the retained blade.The retained blade was surgically retrieved successfully.No further patient follow up required.Due to no manufacturing lot number provided, a review of the device history record could not be completed.The most probable root cause could be contributing to blade detached from handle condition where the handle could be damaged.However, this could not be verified due to no return in sample.Additionally, excessive force applied by the end user during surgery process could contribute to the condition.The following controls are in-place to mitigate blade detached from handle 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.No sample was available for return.Based on this information, no further action is required.
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