It was reported that during a meniscus clean up surgery, when the package was opened the meniscus mender was found damaged, the needle and head was separated.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.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 was returned for evaluation.Visual assessment confirmed the complaint.The loop meniscal were broken from the bottom.To avoid components from shifting within the package, individual component storage cradles are intentionally snug.Use of the distal end (head) to remove snare loops from the tray may result in weakening, bending or complete fracture between at the head and shaft connection.Proper method of retrieval is to push and pop the head of the component from the back of the cradle.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 although the condition was confirmed during further investigation by engineering.This resulted with initiation of a corrective action and potential process change.Engineering evaluation confirmed the product met specifications at the time of distribution.
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