Arthrex® AR-9090-02SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867305502), received between Jun 21, 2024 and Sep 16, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Positioning Failure; Positioning Failure

  ON 08/26/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9090-02S DUALCOMP HINDFOOT NAIL DID NOT ALIGN PROPERLY WITH THE GUIDED ARM AND JIG. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064502 ↗
• MalfunctionApr 23, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  ON 04/10/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9090-02S DUALCOMP HINDFOOT NAIL NITINOL CORD BECAME LOOSE. THIS OCCURRED DURING HINDFOOT FUSION ON (B)(6) 2025, WHEN THEY GOT THE IMPLANT IN AND THE NITINOL CORD BECAME LOOSE OR DID NOT WORK. EVERYTHING WAS REMOVED. THE CASE CONTINUED USING ANOTHER NAIL. THERE WAS A DELAY OF ABOUT 30 MINUTES AND IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21895599 ↗
• MalfunctionJun 21, 2024Break; Difficult to Advance; Break; Difficult to Advance

  ON 05/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE PEEK PIECE HOLDING THE SLIDING INTERNAL COMPONENT OF AN AR-9090-02S DUAL COMP HINDFOOT NAIL BROKE AND ENGAGED DURING INSERTION. THIS CAUSED SLACK WITHIN THE TENSION WIRE BEFORE THE NAIL WAS COMPLETELY INSERTED. THE SURGEON CLEARED THE ANKLE OF THE CARTILAGE AND CORRECTED DEFORMITIES. PLACED TWO 2.4 MM GUIDEWIRES TO HOLD THE ANKLE IN POSITION. PLACED 3MM STARTING GUIDE PIN AND REAMED WITH THE OPENING REAMER UNTIL THE END OF THE FLUTES HAD ENTERED THE CALCANEUS. THE 3MM WIRE WAS REMOVED AND THE BALL TIP WIRE WAS PLACED INTO THE CANAL. THE SURGEON STARTED WITH THE 9MM FLEXIBLE REAMER, INCREASING BY 1MM UNTIL REACHING THE FINAL 12MM REAMER. THEN, SELECTED AN AR-9090-02S DUALCOMP HINDFOOT NAIL, 10.5MM X 210MM, AND LOADED IT AS THE TECHNIQUE GUIDE EXPLAINS. THE SURGEON PACKED ANKLE JOINTS WITH AUTOGRAFT AND ALLOGRAFT BONE. THEN, THE SURGEON BEGAN TO INTRODUCE THE NAIL, WITH IT BECOMING DIFFICULT TO ADVANCE WITHIN THE FIRST 25 PERCENT OF INSERTION. THE STRIKE PLATE WAS ATTACHED, AND THE SURGEON BEGAN TO MALLET THE NAIL. ONCE THE NAIL HAD ADVANCED TO ABOUT HALFWAY, IT WAS NOTICED THAT THE TENSIONING CABLE HAD SLACK

  Patient problems: Insufficient Information

  MAUDE report 19583683 ↗