It was reported that during the surgery, the shaft of the meniscus mender broke off from the gripper when it was being installed in the patient.The surgery was delay by 10 minutes.It is unknown how the surgery was completed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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One 7209485 disposable meniscus mender ii set used for treatment but was not returned for evaluation.To keep components from shifting within the package, the product storage cradles are intentionally snug.The heads of the braided loop components snap into their packaging cavities to avoid inadvertent loop disturbance during removal from their cradles.Removal of a loop from the tray using the distal end (head) can result in weakening, bending or complete fracture between the head and shaft.The correct method of retrieval is to push the head of the component from the back of the cradle which will pop it free.Complaint history review indicated similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Instructions for use contains recommendations and precautionary statements for proper use of product.Risk management files contain the reported failure.Additional investigation by engineering resulted with initiation of a corrective action and potential process change.The product family is under review.Engineering evaluation confirmed the product met specifications at the time of distribution.
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