Arthrex® AR-5035TC-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867035522), received between Feb 3, 2017 and Feb 3, 2017 — 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 3, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE AR-1588-20 RETROBUTTON ((B)(4)) ALONG WITH THE AR-5035TC-11 11 MM X 35 MM DELTA TAPERED BIOCOMPOSITE INTERFERENCE SCREW ((B)(4)) WERE BEING USED IN A KNEE PROCEDURE THAT TOOK PLACE ON (B)(6) 2016. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT DEVELOPED AN INFECTION IN THE KNEE AFTER THE SURGERY AND WAS BROUGHT BACK IN ON (B)(6) 2017 TO DO A WASH OUT. A CULTURE WAS PERFORMED AND FOUND THE PRESENCE OF ASPERGILLUS (A FUNGUS). POST OP X-RAYS WERE ALSO TAKEN AT THIS TIME. ACCORDING TO THE SURGEON, THE PATIENT MAY HAVE TO COME BACK TO HAVE A SECOND SURGERY. UPDATE:01/27/2017- REP STATED THAT THE PATIENT WAS DISCHARGED AND FACILITY INFECTION CONTROL IS LOOKING INTO THIS INCIDENT. NO OTHER SURGERIES HAVE BEEN SCHEDULED.

  Patient problems: Fungal Infection; Unspecified Infection

  MAUDE report 6300544 ↗