The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.A dimensional evaluation of the returned device did not confirmed the stated failure mode.The device met the specifications.The clinical/medical evaluation concluded that this case reports that while using the journey ii cutting blocks metal shavings were produced when drilling.It is unknown if the metal shavings were removed from the patient.Without the requested clinical information, the reported issue could not be further assessed.The material for the device is 17-4 ph stainless steel and is manufactured and intended as an externally communicating device, not approved for implantation; therefore, long-term implantation data is not available.The patient impact beyond possible micro-motion and/or migration, and local irritation/discomfort cannot be determined.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are 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 future complaints and investigate as necessary.We consider this investigation closed.
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