It was reported that, during intertan trauma surgery, it was found that the trigen low profile screw 5.0mm x 25mm (case: (b)(4)) and the long hexdriver (case: (b)(4)) mated incorrectly.The surgery was completed with a less than 30 mins delay using other smith and nephew back-up screw.No other complications were reported.
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The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device shows signs of damage from attempted use.The part shows significant damage at entrance of the hex and can not confirm the if the hex drive feature is conforming prior to attempting to use it.Work-order is also 100% visually checked for parts configuration to print.A review of the dhr performed and did not indicate any issues.However, the implemented controls and detection points are adequate to capture this type of defect and is not considered a systemic issue per history of complaints and non-conformances.Possible causes of the defect are: wore and broken tool and machine variance.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.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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