Arthrex® AR-9090-01SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867305618), received between Apr 30, 2025 and May 6, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2025Positioning Failure; Failure to Advance; Positioning Failure; Failure to Advance

  ON 04/08/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9090-01S DUALCOMP HINDFOOT NAIL SET SCREWS LOST GRIP ON THE CABLE AND THE NITENOL CORE RETRACTED WHEN COMPRESSING THE DUAL COMPRESSION HINDFOOT NAIL AND RENDERED THE NAIL UNUSABLE. THE CASE WAS COMPLETED BY SUCCESSFULLY REMOVING THE NAIL AND IMPLANTING ANOTHER AR-9090-01S DUALCOMP HINDFOOT NAIL. THIS WAS DISCOVERED DURING A TTC FUSION WITH AN INTRAMEDULLARY NAIL PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21970037 ↗
• MalfunctionApr 30, 2025Break; Defective Device; Break; Defective Device

  ON 04/08/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4), AN AR-9090-01S DUALCOMP HINDFOOT FAILED TO TENSION TO THE NECESSARY POSITION, RENDERING IT UNUSABLE. AS A RESULT, THE CASE WAS DELAYED FOR AN UNSPECIFIED PERIOD. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935716 ↗