Arthrex® AR-8750-46HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867262942), received between Sep 26, 2022 and Nov 5, 2024 — classified as 4 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 10/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8750-46H 5.0 LARGE COMPRESSION FT SCREW WELDED TO THE K-WIRE AND WAS REMOVED. THE SCREW AND K-WIRE COULD NOT BE TAKEN APART. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20611044 ↗
• MalfunctionMay 23, 2024Fitting Problem; Fitting Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8750-46H LARGE COMPRESSION FT SCREW DID NOT FIT INTO ANY T15 HEX DRIVERS. A NEW AR-8750-46H LARGE COMPRESSION FT SCREW WAS OPENED TO COMPLETE THE CASE SUCCESSFULLY WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A CALCANEUS OSTEOTOMY PROCEDURE ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19382063 ↗
• MalfunctionSep 26, 2022Break; Material Twisted/Bent

  ON 9/6/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8750-46H, AN AR-8750-42H, AND AN AR-8750-38H 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. 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, 2 OF THE 3 SCREWS WERE BROKEN INSIDE THE PATIENT POST-OP. ACCORDING TO THE X-RAY AND THE SALES REPRESENTATIVE, IT WAS ASSUMED THAT THE AR-8750-46H AND AR-8750-42H 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. ON 09/14/2022, ANOTHER SALES REPRESENTATIVE CALLED AND PROVIDED VIA PHONE THE FOLLOWING INFORMATION: ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED BY THE SAME SURGEON TO REMOVE THE BROKEN AR-8750-46H AND AR-8750-42H FROM THE PATIENT SUCCESSFULLY. BOTH COMPLAINT DEVICES WERE AVAILABLE FOR RETURN.

  Patient problems: Foreign Body In Patient

  MAUDE report 15484138 ↗
• MalfunctionSep 26, 2022Break; Material Deformation

  ON 9/6/2022, 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 15484127 ↗