The associated device was returned and evaluated.A visual inspection of the returned lag screw drill sleeve confirms there is extensive use and wear seen on the device.The device was manufactured in 2009.A functional evaluation was conducted with a mating device and confirms the lag screw drill sleeve will not allow mating device to enter smoothly.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.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 complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.
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