The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The hex head is damaged/ deformed, rendering the device inoperable.The device was manufactured in 2019.The medical investigation concluded that it was communicated that the procedure was completed with a backup device.Per complaint, no patient harm or surgical delay resulted from the event; therefore, no further medical assessment is warranted at this time.The product evaluation revealed that the screw failed the gage for hex depth.This led to the screw not being able to mate for the driver.A review of complaint history did not reveal additional complaints for the listed batch for the same failure mode.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 have reason to suspect that the product failed to meet product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The potential probable cause for this event is likely a manufacturing process error.Based on this investigation, the need for corrective action is 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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