H3, h6: the associated devices, intended for use in treatment, were returned and evaluated.A visual inspection of the returned devices does not confirm the stated failure mode.The devices shows signs of extensive use.The dimensional evaluation could not verify the failure mode as the devices returned on this complaint were verified to be within drawing print specifications and tolerances.The broaches were verified with the appropriate overlays for the tooth profile.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.These devices are reusable instruments that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.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.We consider this investigation closed.
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