The devices, used for treatment, were returned for prior evaluation.Visual inspection revealed that the bone pin had a dull tip.Functional inspection revealed one bone screw was bent (3.5 inches from tip).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.A complaint history review identified prior similar events.We were able to confirm there was a relationship established between the reported event and the device.The malfunctions were likely due to mechanical component failure from bending of the bone screw, use of the bone pins over time, and clamping on the pins at the threads.
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