Device evaluation: the returned rod was visually inspected and no damage was found.Score marks observed on the distraction rod that confirmed the distraction rod was extended approximately 12 mm from its initial position.X-ray images of the internal components showed no damage and revealed the rod was partially distracted.The rod was functionally tested and was able to distract and retract with the erc and manual distractor.The length as received was measured at 228.65 mm.The minimum and maximum lengths were measured at 244.025 and 216.16 mm respectively; giving a total stroke measurement of 28.09mm, which meet the specification.Distraction force testing was measured at 45.50lbs, which meets the specification.The reported failure mode was unable to be confirmed as the rod was fully functional and met acceptance test specifications.Device records review: review of the device history record for the rod confirmed that it met all of the required quality inspections prior to release.
|