It was reported that, during physical therapy, lateral evos 3.5/2.7 distal fibula plate and anterolateral partial articular evos 2.7/3.5 distal tibia plate, broke, therefore a revision surgery was performed on (b)(6) 2021 for plate removal.The current health status of the patient is unknown.
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H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was fractured into two pieces, rendering the device inoperative.All of the fractured pieces were returned.The clinical/medical investigation concluded that, undated x-ray photos provided confirm the reported breakage and a compressed fracture at what appears to be the original fracture location in the distal tibia.Based on the limited information provided the clinical root cause of the reported breakage could not be determined.It was communicated via e-mail that patient is doing well.No further clinical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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