The device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned device confirms from the analysis conducted during this investigation, it was concluded that the anthology inserter fractured at the transition between the shaft and striking platform, most likely from impact.An impact fracture can occur if the mechanical loads applied to the instrument exceed the strength of the material.This fracture caused the instrument to become inoperable.The broken piece was returned with the device.The device was manufactured in 2014.The device exhibits signs of significant wear and use.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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 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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