It was reported that during a shoulder cuff repair surgery, after drilling the bone hole, the footprint ultra anchor broke in the bone hole after implantation and the suture fell off.The procedure was completed using a smith and nephew back up device in an additionally drilled bone hole.There was a delay greater than 30 minutes and no further complications were reported.
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H10: h3, h6: part of the reported device was received for evaluation.A visual inspection found a product box with the labeled poly bag, ifu and chart-stik label sheet was returned.The insertion device, suture strings or anchor were not returned.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the material specifications found that the storage requirements and applicable tests were appropriately specified.A material certificate of analysis was required for the raw material.A clinical review states one undated, unlabeled intra-operative fluoro image was provided and confirms the piece of the anchor within the bone hole at the time.Based on the limited information provided, the definitive root cause of the reported anchor breakage could not be determined.The implantable anchor was retained inside of the patient¿s bone, therefore, micro-motion and/or migration is unlikely.The root cause could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the failure include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
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