It was reported that, during an internal fixation surgery, a honeycomb was chipped at the end.This happened before use in patient.Surgery was performed, without any delay, with a back-up device instead.Patient was not injured as consequence of this problem.
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H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned honeycomb confirms the device is chipped on the end.This device also has extensive wear usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument 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.
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