On (b)(6) 2022, it was reported by sales representative via email that an ar-4158ds-16b dynamite hammertoe screw ended up chewing away at the bone canal and it was not secure.Surgeon analyzed the inserter and realized the implant was placed on the inserter incorrectly, the bent portion was facing the wrong way.This did not allow the screw to be inserted straight, causing the failure at the bone canal during.This was discovered during a procedure on (b)(6) 2022.Additional information received on 5/31/2022: this was discovered during a hammertoe procedure and completed with the same ar-4158ds-16b dynamite device by inserting the dynamite hammertoe portion and using a k-wire to pin the toe since it destroyed the middle phalanx due to being on the inserter in the opposite direction.Nothing broke inside the patient and no further issues has been reported.
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