H10: h3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The insertion device and a fractured anchor were returned.The insertion device has been bent and the metal is fractured opposite the bend, the prongs at the distal end are deformed and partially fractured.The proximal end of the anchor war returned without the distal end above the suture window.All returned items have debris on them.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 raw material strength and storage requirements are specified and each lot must be accompanied by a material certificate of analysis.The root cause has been associated with with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the 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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