A polarus 3 proximal nail was implanted on (b)(6) 2020.On (b)(6) 2021, it was explanted due to nail loosening and infection.The technique used by the surgeon is thought to be the root cause of the issue.This was reported in medwatch 3500a report number: 3025141-2021-00119.Email communication was received from the field on 24 january 2022 indicating screw with part number 3011-43022 was also involved.The complaint record was updated with this information.The device was received for evaluation on 31 january 2022, and the evaluation was completed on 7 february 2022.This event is also related to reports 3025141-2022-00028 and 3025141-2022-00029 which were submited for other screws involved in this event.
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The device was received for evaluation on 31 january 2022, and the evaluation was completed on 7 february 2022.Manufacturing and inspection records were reviewed, and no anomalies were found.The returned products were visually inspected under magnification.4.3mm x 22mm low profile hexalobe screw (pn 3011-43022) the 4.3mm x 22mm low profile hexalobe screw had batch number confirmed as 442132.The head of the screw showed significant scratches denting and deformation.The hexalobe recess is significantly scratched and dented as well.Many of the threads across the length of the screw are shiny, dented and deformed indicating stripping.No other significant signs of damage are visible on the screw.It is not possible to determine if these signs of damage occurred during implant, use or explant.Possible reasons for the damage seen in the screw include damage incurred during the explant procedure or improper following of the surgical technique.Therefore, no definitive conclusion can be made.Quality will continue to monitor for trends.
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