Arthrex® AR-8750-50HRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867262966), received between Dec 20, 2019 and Nov 8, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2024Break; Break

  ON 10/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8750-03 DRIVER SHAFT, T15 HEXALOBE, CANNULATED HAD THE TIP OF THE SCREW BREAK OFF IN THE HEAD OF THE SCREW WHEN THE SURGEON WAS TRYING TO BACK OUT THE SCREW. THE CASE WAS COMPLETED SUCCESSFULLY, WITH NO PIECES BREAKING OFF INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A HARDWARE REMOVAL PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 11/04/2024: THERE WAS NO CASE DELAY. THE HARDWARE REMOVAL PROCEDURE WAS FOR THE REMOVAL OF THE ARTHREX PART AR-8750-50H 5.0 LARGE COMPRESSION FT SCREW, WHICH WAS EXPLANTED DURING THE SURGERY. AT THIS TIME, IT IS UNKNOWN WHY THE PATIENT UNDERWENT REVISION SURGERY. NO ARTHREX PRODUCTS WERE IMPLANTED DURING THIS SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 20642248 ↗
• MalfunctionSep 26, 2022Break; Material Deformation

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8750-42H, AN AR-8750-46H, AND AN AR-8750-50H HAD ISSUES. DURING A FULKERSON OSTEOTOMY PROCEDURE ON (B)(6) 2022, ALL THREE COMPLAINT DEVICES WERE IMPLANTED, AND THE CASE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT. IT WAS REPORTED THAT THE PATIENT HAD A POST-OP INFECTION THREE WEEKS AFTER SURGERY. ON (B)(6) 2022, THE X-RAY WAS SHOWING THAT 2 OF 3 SCREWS WERE BENDING. ON (B)(6) 2022, ON THE NEXT X-RAY, ONE OF THE SCREWS HAD BROKEN POST-OP INSIDE THE PATIENT. ON (B)(6) 2022, TWO OF THE SCREWS WERE BROKEN INSIDE THE PATIENT POST-OP. ACCORDING TO THE X-RAY AND THE SALES REPRESENTATIVE, IT WAS ASSUMED THAT THE AR-8750-50H AND AR-8750-46H WERE BROKEN. THE BROKEN SCREWS WERE SECURELY AFFIXED INSIDE THE PATIENT, AND THE SURGEON WAS NOT PLANNING A REVISION SURGERY AND DEEMED IT SAFE TO LEAVE THE BROKEN SCREWS INSIDE THE PATIENT, BUT JUST WANTED TO HAVE THE COMPLAINT REPORTED. THE PATIENT IS FINE TO DATE.

  Patient problems: Unspecified Infection

  MAUDE report 15484137 ↗
• InjuryDec 20, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED AFTER FOOT RECONSTRUCTION PROCEDURE ARTHROCELL WAS USED. THE PATIENT HAD AN ADVERSE REACTION INCLUDING FEVER SPIKES ONE DAY POST-OP. THERE WERE ALSO FOUR SCREWS AND TWO STAPLES IMPLANTED. NO REVISION IS PLANNED AT THIS TIME. CURRENTLY THE DOCTOR IS RESEARCHING THE SOURCE OF THE REACTION.

  Patient problems: Fever

  MAUDE report 9506213 ↗