The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The threaded tip of the device fractured off and was not returned.The device was manufactured in 2009 and exhibits signs of extensive wear/usage.The tip fracture is most likely due to impact forces.If during impaction, sufficient side loads are transferred to the tip of the device, a mechanical overload or fatigue fracture can occur.Additionally, if the tip is damaged due to such impact forces to the extent that it influences connection to the hip stem, there may be difficulty when trying to remove the device from the implanted stem and the device may fracture during removal.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.
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