Arthrex® AR-8750-42HRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867262928), received between Sep 26, 2022 and Oct 17, 2022 — classified as 1 injury, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2022Break; Material Twisted/Bent

  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, 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-8750-50H 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. ON 9/26/2022, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION ON THE PHONE: THE POST-OP INFECTION THREE WEEKS AFTER SURGERY HAD OCCURRED ON THE SURGICAL SITE OF

  Patient problems: Unspecified Infection

  MAUDE report 15614884 ↗
• MalfunctionSep 26, 2022Break

  ON (B)(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 06/03/2022, 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 (B)(6) 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 15484141 ↗