Arthrex® AR-9090-06SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867305540), received between Mar 12, 2024 and Nov 21, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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.

• MalfunctionNov 21, 2025Failure to Advance; Failure to Advance

  ON 11/3/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL AN ISSUE WITH AN AR-9090-06S DUALCOMP HINDFOOT NAIL. THE CASE WAS PROGRESSING WELL UNTIL STEP 3, THE COMPRESSION STAGE. ALTHOUGH THE T-HANDLE ALLOWED THE NAIL TO BOTTOM OUT, THE INTERNAL COMPONENTS DID NOT SLIDE DOWN AS EXPECTED, MAKING IT IMPOSSIBLE TO PLACE THE SECOND CALCANEAL SCREW. IMAGING WAS REVIEWED, AND THE NAIL WAS REMOVED. UPON INSPECTION, IT WAS FOUND THAT THE CABLE HAD SLIPPED ON ONE SIDE. THE CABLE WAS RELOADED, AND THE FIRST TWO SCREWS WERE REPLACED. HOWEVER, THE SAME ISSUE OCCURRED AGAIN; THE INTERNAL MECHANISM FAILED TO SLIDE AND OPEN THE DRILLING WINDOW. AT THAT POINT, A SECOND NAIL WAS OPENED AND FUNCTIONED AS INTENDED, ALLOWING THE PROCEDURE TO BE COMPLETED SUCCESSFULLY. THIS ISSUE WAS DISCOVERED DURING A TTC NAIL PROCEDURE PERFORMED ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 11/11/2025: IT WAS CONFIRMED THAT THE SAME SCREWS USED WITH THE FAULTY NAIL WERE ALSO UTILIZED WITH THE REPLACEMENT AR-9090-06S DUALCOMP HINDFOOT NAIL TO COMPLETE THE PROCEDURE. THE CASE EXPERIENCED AN APPROXIMATE DELAY OF 35 MINUTES, AND IT REMAINS UNKNOWN WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622188 ↗
• MalfunctionMar 18, 2025Positioning Failure; Positioning Failure

  ON 3/3/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-9090-06S DUALCOMP HINDFOOT NAIL HAD AN ISSUE DURING A HINDFOOT NAIL PROCEDURE ON (B)(6) 2025. DURING THE TENSIONING PORTION OF THE CASE, THE CABLE FRAYED, AND THE INNER CORE OF THE NAIL COULD NOT BE TENSIONED. THE HINDFOOT NAIL WAS EXPLANTED FROM THE PATIENT IN ONE PIECE TOGETHER WITH THE FRAYED CABLE. EVERYTHING WAS REMOVED FROM THE PATIENT, NOTHING BROKE INSIDE THE PATIENT, AND THERE WAS NO HARM. THE SCREWS WERE ALSO EXPLANTED AND THEN REUSED TOGETHER WITH A NEW AR-9090-06S DUALCOMP HINDFOOT NAIL WITH THE SAME LOT NUMBER, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE COMPLAINT DEVICE WAS DISCARDED, BUT PICTURES WERE TAKEN. THE CASE WAS DELAYED FOR MORE THAN 15 MINUTES, AND IT COULD NOT BE CONFIRMED IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632685 ↗
• MalfunctionMar 12, 2024Defective Device; Defective Device

  ON 2/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9090-06S DUALCOMP HINDFOOT NAIL MALFUNCTIONED. THIS WAS DISCOVERED DURING A PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18887456 ↗