H10: h2: additional information on h6.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 was returned with the proximal end of the anchor in place.The suture strings were not returned.The distal end 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.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 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, off-axis insertion, or an inadvertent impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
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