It was reported that, during a tibial nail surgery, trauma interface couldn't be turned on and free hands were used to complete the surgery.The affected complaint device, used in treatment, was not returned for evaluation.Therefore product analysis could not be performed at this time.However, pictures were provided which could not confirm the stated failure.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.No patient injuries or adverse consequences were reported, the patient status was reported as ¿good.¿ since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.The device user manual is available, identifying pre-operative requirements for use and suggesting that the targeter should be connected at least 10 minutes prior to targeting.
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