H10: internal complaint reference: (b)(4).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 with no suture material.The anchor is fractured at the suture window and the fins at the proximal end are deformed.There is debris on all returned items.Based on the condition of the product material found during visual inspection, additional material testing is not required.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was 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 material specifications found the raw material strength and storage requirements specified and each lot be must be accompanied by a material certificate of analysis.A clinical review states one undated image of the device was provided for review and display the anchor with a missing tip.It is unknown if the tip was retrieved from the patient.Based on the information provided no clinical factors were found which would have contributed to the reported breakage.The footprint suture anchor is implantable, biocompatibility is not an issue.If retained micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.The root cause was associated 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, attempted correction of a damaged device, or an inadvertent impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
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