The reported multifix s-ultra 5.5mm knotless anchor device, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual evaluation cannot be performed and customer¿s complaint cannot be confirmed.From the information provided, ¿the anchor has been implanted normally in the humeral head during rotator cuff surgery, but the patient came after a week with pain.The x-ray showed a piece of metal implanted along with the anchor¿.An exact root cause cannot be determined with confidence.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
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