Arthrex® AR-300-B101Recalls & reported problems
Arthrex, Inc. · BURR, CONICAL, 13MM, 4.3 MM · Class 1
Data updated Oct 16, 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 00888867028647), received between Apr 12, 2024 and Sep 9, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Difficult to Insert1
- Fitting Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2025Difficult to Insert; Fitting Problem; Difficult to Insert; Fitting Problem
ON 08/18/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-300-B101 WILL NOT STAY LOCKED IN. DISCOVERED DURING A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFO 8/28: CASE WAS CONTINUED AND COMPLETED NON ARTHREX DEVICE AND BURR. NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23000601 ↗MalfunctionApr 12, 2024Break; Break
ON 3/21/2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY NURSE REPORTED THAT AN AR-300-B101 BURR TIP BROKE OFF INSIDE THE PATIENT'S FOOT DURING THE PROCEDURE. NO INJURY TO THE PATIENT OCCURRED, AND ALL THE PIECES OF THE BURR WERE REMOVED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19098625 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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