Arthrex® AR-9091-31Recalls & reported problems
Arthrex, Inc. · Hindfoot Nail, Impaction Rod · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867334922), received between Nov 14, 2024 and May 29, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2026Break
ON 8-MAY-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9091-31 IMPACTION ROD BROKE DURING A CASE. NOTICED DURING A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25332240 ↗MalfunctionNov 14, 2024Break; Break
ADDITIONAL INFORMATION PROVIDED ON 11/13/2024 BY A SALES REPRESENTATIVE WHO STATED THE EVENT OCCURRED ON (B)(6) 2024 AND THE PROCEDURE PERFORMED WAS A HINDFOOT FUSION. THE IMPACTOR PAD SNAPPED OFF IN THE TARGETER DURING IMPACTION OF THE NAIL. AN ARTHREX REP WAS PRESENT DURING THE CASE. THE PATIENT'S BONE QUALITY WAS AVERAGE. NO FRAGMENTS BROKE OFF IN THE PATIENT. THERE WAS NO ADDITIONAL ANESTHESIA NEEDED AND NO DELAY TO THE PROCEDURE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20687070 ↗
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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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