H10, h3, h6: the device, intended for use in treatment, was returned for evaluation.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.We were able to confirm if there was a relationship established between the reported event and the device.Visual inspection of the returned bone pin found that the threads were damaged and there was mechanical component failure.A factor that could have contributed to damaged threads is if the bone pin had been clamped.
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