It was reported that during a shoulder cuff repair surgery, using specialized tools to tap, the end of the anchor of the twinfix ultra broke after 2/3 of the implantation.The procedure was successfully completed with a delay of less than 30 minutes using a smith and nephew back up device.All pieces removed using tweezers.The back up device was used in the originally bone hole so there was no void left in the patient.No further complications were reported.
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H3, h6: the reported device was received for evaluation.A visual inspection revealed that the returned device was not in its original packaging.The insertion device was returned with the proximal end of the anchor in place.The suture strings were not returned.The distal 2/3 of the anchor is fractured away from the proximal end of the suture window and was not returned.The prongs at the distal end of the insertion shaft are deformed.There is biological debris on the returned items.An assessment of material characteristics found that based on the condition of the product material found during visual inspection, additional material testing is not required.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.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 for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.The root cause has been associated with unintended use of the device.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.No containment or corrective actions are recommended at this time.
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