Internal complaint reference case-(b)(4).H10 h3, h6: the reported device was returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the customer provided image reveals the inner blade is fractured and worn.A visual inspection revealed the device was received outside of original packaging.The inner blade distal tip was fractured.A functional evaluation reveals the device does not function as intended due to fracture of the inner blade.It was determined the device contributed to the reported event.The complaint was confirmed.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate application, excessive force and side loading of the device.No containment or corrective actions are recommended at this time.
|