This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint is not confirmed.One unpackaged ar-2324pslc-1 serial/batch number 15026035 was received for investigation.Eyelet, screw, and sutures are attached to the device.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.Functional testing between the driver outer sleeve and the tb inner member molded swivelock found that the two devices rotate smoothly.Visual evaluation did not find issues with the returned device.No problem with the returned device.
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