It was reported that during a lateral meniscus repair surgery, after drilling the bone hole, the footprint ultra anchor head broke during the implantation.The procedure was completed using a smith and nephew back up device.There was a delay less than 30 minutes and no further complications were reported.
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H10: h3, h6: the reported device was received for evaluation.A visual inspection revealed that it is not in its original packaging.The insertion device was returned with the suture strings off the device.The proximal end of the anchor is on the insertion device with the proximal anchor in place and not actuated.The distal end of the distal anchor is fractured away at the proximal end of the suture window.There is biological debris on the returned items.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, material specifications, and applicable tests were appropriately specified.A material certificate of analysis was required for the raw material.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 inconsistent with normal use.No containment or corrective actions are recommended at this time.
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