The associated complaint devices were returned and evaluated.A visual inspection of the returned devices indicated surface damage and wear from use.These devices were manufactured ranging from four to eleven years ago.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A functional evaluation indicated that we were able to properly duplicate the surgical technique with all the mating components and found no issue with the alignment.All the mating components met the drawing specification and assembled with no issues.Based on the evidence available to us, we are unable to determine a possible issue with the devices; the need for corrective action is not indicated.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
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