It was reported that after an initial bunion surgery on (b)(6) 2021, all hardware was removed in a revision surgery on (b)(6) 2021 due to a screw that was backing out.The patient was revised with new tmc hardware which was subsequently removed on (b)(6) 2022 due to hardware irritation.Upon removal, there were no deficiencies or malfunctions alleged/found with any tmc device and no other patient outcomes were reported as a result of this event.
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It was reported that after an initial bunion surgery on (b)(6) 2021, all hardware was removed in a revision surgery on (b)(6) 2021 due to a screw that was backing out.The patient was revised with new tmc hardware which was subsequently removed on (b)(6) 2022 (mdr #3011623994-2022-00068) due to tendon irritation.Upon removal, there were no deficiencies or malfunctions alleged/found with any tmc device and no other patient outcomes were reported as a result of this event.The devices were not returned to the manufacturer for evaluation.Device specific information was not available, therefore a review of device history records was not able to be performed.However, non-conformance reports for all possible kits utilized in surgery were reviewed and no issues were identified during the manufacture and release of the device that could have contributed to what was reported.Based on the available information, the most likely root cause cannot be determined due the device not being returned for evaluation.However, it is possible the initial placement of the screw and/or post-operative activity of the patient led to loosening and an eventual backing out of the screw.The instructions for use identifies warnings related to postoperative care and the surgical technique instructs on the proper method for inserting screws.The company will supplement the mdr as necessary and appropriate.
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