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Arthrex® AR-400BRecalls & reported problems

Arthrex, Inc. · BURR ATTACHMENT 2.35MM · Class 1

Data updated Oct 13, 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 00888867223615), received between Apr 25, 2022 and Apr 25, 2022 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

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.

  • MalfunctionApr 25, 2022Break

    ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-400B BURR ATTACHMENT BROKE. THIS WAS DISCOVERED DURING USE IN A PROCEDURE. ADDITIONAL INFORMATION REQUESTED.

    Patient problems: Insufficient Information

    MAUDE report 14195571 ↗

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Sources and updates

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