Arthrex® AR-9090-04SRecalls & reported problems
Arthrex, Inc. · DualComp Hindfoot Nail, 10.5 x 300 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 00888867305526), received between Mar 15, 2024 and Mar 15, 2024 — 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
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 15, 2024Failure to Advance; Failure to Advance
ON 02/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-9090-04S DUALCOMP HINDFOOT NAIL COULD NOT BE IMPLANTED. THIS OCCURRED DURING A DUAL COMPRESSION TTC NAIL CASE WHEN TENSIONING THE CABLE FOR THE COMPRESSION MECHANISM; THE HANDLE MAXED OUT IN THE TENSIONER. WHEN THEY WENT TO DRILL THE PROXIMAL CALCANEAL SCREW (THIRD SCREW INTO THE NAIL), THE TRAJECTORY THROUGH THE JIG WAS BLOCKED BY THE INTERNAL SLIDING MECHANISM OF THE NAIL. IT WAS AT THIS POINT THAT THEY REALIZED THE INTERNAL SLIDER HAD NOT REACHED ITS MAXIMUM DISTANCE. THEY TRIED TO TROUBLESHOOT ON THE FLY, SEEING IF THEY COULD FORCE THE SLIDER DOWN THROUGH A SCREW HOLE OR SEE IF ANYTHING WAS BLOCKING THE MECHANISM, BUT WERE UNABLE TO MOVE THE SLIDER.
Patient problems: Insufficient Information
MAUDE report 18916338 ↗
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- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
- PRECICE Intramedullary Limb Lengthening System LSB5-040Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls0 reports
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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