The returned devices, intended for use in treatment, were returned as mdr¿s for evaluation.There were a relationship found between the returned devices and the reported incident.Visual inspection of the returned magnum2 knotless implant om-1502 shows deployed devices.There are no manufacturing abnormalities visually observed with the returned instruments.The magnum2 knotless is a single used device and cannot be functional tested.An attempt was made to test the basic functions of this instrument.The complaint was not verified and the root cause could not be determined with certainty.Factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: improper suture loading, excessive tensioning or improper alignment of the inserter handle with the bone hole.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.Company representative should be blank.
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