Arthrex® AR-9090-10SRecalls & reported problems
Arthrex, Inc. · DualComp Hindfoot Nail, 12.5 x 210 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 00888867305588), received between Dec 17, 2025 and Dec 17, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 17, 2025Failure to Advance; Failure to Advance
ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-9090-10S, DUALCOMP HINDFOOT NAIL, 12.5 X 210 MM, THE SURGEON WAS IMPLANTING A DUAL COMPRESSION HINDFOOT NAIL WHILE FOLLOWING THE TECHNICAL GUIDE PRECISELY, THE HIND FOOT NAIL WAS LOADED ONTO THE INSERTION JIG AS PER TECHNIQUE. THE TENSION CABLE WAS LOADED PRECISELY AS PER TECHNICAL GUIDE. THE TENSION SCREWS WERE AT THE MOST PROXIMAL END ON THE TENSION GUIDE. ALL SLACK WAS REMOVED FROM THE TENSION CABLE AS IT WAS INSERTED INTO THE TENSION GUIDE. THE TENSION GUIDE SCREWS WERE TIGHTENED WITH 3 CLICKS OF THE TORQUE LIMITER. THE HIND FOOT NAIL WAS INSERTED INTO THE PATIENT. THE MOST DISTAL CALCANEAL SCREW WAS INSERTED SUCCESSFULLY. THE MOST DISTAL TIBIAL SCREW WAS INSERTED SUCCESSFULLY. THE SURGEON USED THE T HANDLE TO TENSION THE NITINOL CORE OF THE NAIL. THIS WAS TIGHTENED UNTIL IT HIT A HARD STOP. THE SURGEON THEN DRILLED FOR THE PROXIMAL CALCANEAL SCREW. THE DRILL WOULD NOT PASS THROUGH THE NAIL BECAUSE THE NITINOL CORE HAD NOT STRETCHED DOWN TO EXPOSE THE NITINOL CORE DRILL HOLE. ON FURTHER LATERAL INSPECTION THE TALUS NAIL HOLE WHICH SHOULD BE OF AN OVAL OR ELONGATED SHAPE IF THE NITINOL CORE HAD CORRE
Patient problems: Foreign Body In Patient
MAUDE report 23829165 ↗
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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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