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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

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