It was reported that after an initial bunion surgery, all hardware was removed in a revision surgery due to a failed correction and the patient was revised with non-tmc hardware.No devices were returned for evaluation.The device history records for all possible sk14 and sk12 used in the case were reviewed and no issues were identified during the manufacture or release of the devices that could have contributed to what was reported.Although a number of factors could have contributed to the removal of the hardware, based on the limited information available and unsuccessful attempts to obtain additional information, the most likely cause of what was reported cannot be determined.No malfunctions have been alleged/found with any tmc hardware, nor was it a determining factor for performing the revision surgery.The other devices explanted in the same revision surgery were also tmc devices which were reported in mdr 3011623994-2021-00065.The company will supplement this mdr as necessary and appropriate.
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