The associated complaint devices were returned and evaluated.A visual inspection of the returned meta-tan drill guide confirms the stated failure.The device is fractured at handle/femoral wings connection.From the analysis conducted during this investigation, it was concluded that the drill guide handle portion fractured mostly likely due to overload.An overload fracture can occur if the mechanical loads applied to the drill guide exceeded the strength of the material.It is likely the fracture initiated due to repeated impact strikes during repeated nail insertion use.It was unknown if the fracture in the drill guide handle was initiated in a prior surgery.The device exhibits signs of repeated use and significant wear.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.The clinical/medical team concluded, it was reported that there was a crack in the metatan targeter, resulting in a procedural delay.No patient injury was sustained as a result of this device related incident aside from the extended surgery time, and the procedure was completed successfully.No further medical assessment is warranted based on the information provided.If new information is received in the future, this complaint can be re-opened.We consider this investigation closed.
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