Note corrections to d9/h3 device was returned to manufacturer.The reported event could be confirmed, since the device was returned and found to be in the condition reported.The device inspection revealed the following: visual inspection: the received hex driver shows signs of intense usage.The drill was found to be broken at the hex tip.The remaining edges of the hex tip are blunt and appear to be slightly twisted.The breakage surface reveals a smooth surface.This confirms a sudden brittle fracture.All these signs are evident enough to suggest that there was an intense usage of the driver including high torsional and bending load which led to a forced fracture.Functional inspection: due to the nature of the returned device, a functional inspection was not possible.As per the dimensional inspection and hardness testing, the returned driver was found to be within specifications.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on the investigation, the root cause was attributed to misuse of the device / failure to follow the surgical technique.If any further information is provided, the complaint report will be updated.
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