Arthrex® AR-8840CL-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867048164), received between Feb 26, 2020 and Feb 26, 2020 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD VARIOUS ARTHREX SCREWS IMPLANTED DURING AN ANKLE FIXATION PROCEDURE. THE (B)(6) OFFICE CONTACTED ARTHREX REQUESTING MATERIAL COMPOSITIONS OF THE IMPLANTED PRODUCT AS THEY ARE CONCERNED THAT THE PATIENT MAY BE HAVING AN ALLERGIC REACTION TO THE METALS IN THE SCREWS. THE FOLLOWING ARTHREX PART NUMBERS WERE PROVIDED BY THE ALLERGIST; AR-8840-16, AR-8840CL-35, AR-8840CL-40. THE ALLERGIST IS REQUESTING THE MATERIAL COMPOSITIONS OF THE SCREWS TO TEST THE PATIENT FOR THE APPROPRIATE METALS. AT THIS TIME NO ADDITIONAL DETAILS OR INFORMATION HAS BEEN PROVIDED TO ARTHREX REGARDING THE TYPE OF SYMPTOMS THE PATIENT IS EXPERIENCING, AND/OR THE SPECIFIC CASE DETAILS. ADDITIONAL INFORMATION RECEIVED ON 02/13/2020: THE ALLERGIST REPORTED THE ORIGINAL PROCEDURE TOOK PLACE IN (B)(6) 2014. THE PATIENT WAS EXPERIENCING SWELLING AND PAIN, AND A REVISION PROCEDURE WAS PERFORMED IN (B)(6) 2015. THE IMPLANTED SCREWS WERE REMOVED DURING THE REVISION PROCEDURE. THE ALLERGIST REPORTED THE PATIENT IS CURRENTLY EXPERIENCING ANKLE PAIN AND SWELLING YEARS AFTER HAVING THE SCREWS COMPLETELY REMOVED.

  Patient problems: Pain; Swelling

  MAUDE report 9756726 ↗