Arthrex® AR-9094-11-2030Recalls & reported problems
Arthrex, Inc. · Trochanteric nail, 11mm x 20cm x 130° · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867411708), received between Feb 2, 2026 and Mar 30, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Positioning Failure1
Patient problems
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE NAILING OF THE PROXIMAL FEMUR ON (B)(6) 2026, THE TELESCOPING LAG SCREW WAS INSERTED INTO THE BONE AT THE WRONG ANGLE. DUE TO THIS FAILURE THE SURGEON ATTEMPTED TO REMOVE THE SCREW, HOWEVER DUE TO THE INCORRECT INSERTION THE SCREW BECAME JAMMED. THE SURGEON DECIDED THAT THE FIXATION SHOULD BE SUFFICIENT AND THEREFORE THE SCREW WAS LEFT IN PLACE. IT WAS FURTHER REPORTED THAT DURING THE ATTEMPT OF REMOVING THE SCREW, THE INSTRUMENTS USED WERE BENT AS WELL. NOT LONG AFTER THE INITIAL SURGERY, IT WAS DISCOVERED THAT THE IMPLANTED DEVICE HAD FAILED AND THE NAIL HAD DETACHED FROM THE BONE. FOR THIS REASON, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2026, DURING WHICH ALL PARTS WERE REPLACED WITH NEW DEVICES WITH THE SAME PART NUMBERS. EXCEPT THE SURGEON DECIDED TO USE A NAIL WITH A LONGER SHAFT TO ENSURE PROPER FIXATION. THE REVISION SURGERY WAS PERFORMED SUCCESSFUL, AND NO FURTHER ACTION IS PLANNED.
Patient problems: Failure of Implant
MAUDE report 24711879 ↗MalfunctionFeb 2, 2026Positioning Failure
ON 08-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9094-090L LEFT LAG SCREW, AN AR-S0100-381 GUIDE PIN, AN AR-S0457-000 ACTIVATION TOOL, AR-S0100-000 GUIDE PIN, AR-S0219-100 DRILL, AR-S0209-200 DRILL, AR-9094-11-2030 TROCHANTERIC NAIL, AND AN AR-9094-085L LAG SCREW WERE USED IN A CASE AND NEITHER SCREW WERE ABLE TO LOCK INTO THE NAIL AFTER IMPLANTATION. ALL IMPLANTS WERE FULLY EXPLANTED, AND THE SURGERY WAS COMPLETED USING A COMPETITOR PRODUCT NAIL. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. DELAY IN CASE 50 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24234367 ↗
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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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