H10: h2: additional information: h6: medical device problem code.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 prongs on the distal end deformed.The anchor was returned fractured from the proximal end of the suture window toward the proximal end.The suture strings were returned.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 tensile strength requirements are specified.A material certificate of analysis (coa) is required for raw material.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failures 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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