Arthrex® AR-9090-11SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867305595), received between Feb 26, 2025 and Feb 26, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (1 report).

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

• MalfunctionFeb 26, 2025Positioning Failure; Positioning Failure

  ON 02/13/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9090-11S DUALCOMP HINDFOOT NAIL HAD AN ISSUE WHEN TENSIONING THE NAIL ON STEP 3 ON THE JIG. THE COMPRESSION DEVICE BOLTS WERE "BOTTOMED OUT" DURING TENSIONING AND "ZEROED OUT" BEFORE INSERTION. HOWEVER, THE NITINOL CORE IN THE NAIL DID NOT FULLY OPEN UP THE TALAR SCREW OR THE SUPERIOR CALC SCREW. THEY HAD TO REMOVE THE NAIL AND USE A DIFFERENT ONE AS THE SURGEON WAS CONCERNED ABOUT NOT HAVING ENOUGH POINTS OF FIXATION DUE TO THE ISSUE. THEY BELIEVE THE NITINOL CORE BEGAN TO MOVE AND THEN GOT STUCK AND WOULD NOT OPEN UP THE TALAR SCREW OR SUPERIOR CALC SCREW ANYMORE. THEREFORE, THEY HAD TO REMOVE AND REPLACE THE NAIL WITH ANOTHER NAIL WITHOUT ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 02/18/2025: NO REPORTED PIECES OF THE AR-9090-11S DUALCOMP HINDFOOT NAIL BROKE OFF INSIDE THE PATIENT. THE PROCEDURE WAS DELAYED BY 45 MINUTES, AND BECAUSE IT TOOK AN ADDITIONAL 45 MINUTES, ADDITIONAL ANESTHESIA WAS ADMINISTERED, BUT THERE IS NO REPORT OF THE EXACT QUANTITY ADMINISTERED. THE CASE WAS COMPLETED USING A DIFFERENT ARTHREX

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21470004 ↗