It was reported that during a knee arthroscopy, the acufex retrograde drill's blade was not working correctly, no more details are available.No additional patient information is available.The procedure was successfully completed with a non-significant surgical delay using a smith and nephew back up device.No further complications were reported.The results of investigation revealed the entire distal end was fractured away and returned with the drill guide.Also its actuator was stuck in the fully extended position and it has biological debris.
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H3, h6: the reported device was received for evaluation.A visual inspection revealed it is not in its original packaging.The returned device has the entire distal end fractured away and returned on the drill guide.The actuator is stuck in the fully extended position.There is biological debris on the returned items.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, 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 has been associated with unintended use of the device.Factors that could have contributed to the failure include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
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