The reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The drill was returned with the antegrade drill fractured off the shaft and the retrograde drill still attached to the antegrade drill.The retrograde drill is connected to the distal end of the actuator wire and the actuator wire is fractured at the distal end and disconnected from the grey slider at the proximal end.There is biological debris on the returned items.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.The root cause was associated with an unintended use of the device.Factors that could have contributed to the reported event include excessive force during use, failure to retract the guidewire far enough back before attempting to deploy the blade, using the reverse function while drilling, attempting to deploy the blade while still inside the bone tunnel, or an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
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