It was reported that after an initial bunion surgery on (b)(6) 2023 all hardware was removed on (b)(6) 2024 due to over-correction.The site was revised with tmc hardware.No devices were returned for evaluation.The device history records were reviewed and no issues were identified during the manufacture and release of the devices that could have contributed to what was reported.The most likely cause of the reported event could not be determined as the device was not returned for evaluation.However, additional information indicates it is possible that over tightening of the postioner during the original surgery could have contributed to what the patient experienced.There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any reported issues with the placement of the device or healing of the surgical site.The company will supplement this mdr as necessary and appropriate.Additional tmc hardware explanted in the same revision surgery was reported in mfr report # 3011623994-2024-00045.
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