The associated screw was returned and evaluated.The associated plate was not returned for evaluation.A visual assessment of the screw could not confirm the stated failure mode.The screw did show significant wear/damage in the hex region.The assessment of the surgical images provided by the customer did confirm the stated failure mode.A whole in the plate did not have tabs suggesting a screw did pass through the whole and therefore did not function as intended.The clinical medical investigation concluded that no further assessment was warranted at this time.Based on reported clinical information provided in addition to the product evaluation, the root cause of the broken component was a user/procedural event.The future impact to the patient cannot be determined.A review of complaint history did not reveal additional complaints for the listed plate batch.A review of the manufacturing records for the plate did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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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