Arthrex® AR-9090-03SRecalls & reported problems
Arthrex, Inc. · DualComp Hindfoot Nail, 10.5 x 240 mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867305519), received between Mar 6, 2024 and Mar 6, 2024 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2024Defective Device; Defective Device
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-9090-03S DUAL COMP HINDFOOT NAIL WAS DEPLOYED EARLY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) /2024. ADDITIONAL INFORMATION RECEIVED ON 2/16/2024: THIS WAS DISCOVERED DURING A TTC NAIL PROCEDURE. THE SALES REPRESENTATIVE HAD MARKED THAT A PATIENT INJURY OCCURRED; HOWEVER, AFTER FURTHER CLARIFICATION, IT WAS CONFIRMED THAT THERE WAS NO INJURY TO THE PATIENT. NOTHING BROKE INSIDE THE PATIENT AND THE CASE WAS COMPLETED BY REMOVING THE NAIL THAT DEPLOYED EARLY AND USING AN AR-9090-02S DUAL COMP HIND FOOT NAIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18846113 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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