H10: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The end of the device is missing paint and broken, rendering the device inoperative.The clinical/medical evaluation concluded that this complaint was reported via medwatch.However, neither the requested relevant clinical information nor the device was provided.Therefore, a thorough medical investigation cannot be rendered nor could a definitive clinical root cause of the reported failure be determined.The impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.As the device broke and it cannot longer fit its purpose, the contribution of the device to the reported event could be corroborated.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, or injury.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.Internal complaint reference number: (b)(4).
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