Arthrex® AR-9300RBTRecalls & reported problems
Arthrex, Inc. · BURR, ROUND, 10 FLUTE, 3.0MM · Class 1
Data updated Oct 16, 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 00888867215696), received between Mar 8, 2024 and Mar 8, 2024 — 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. 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
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 8, 2024Break; Break
ON 02/27/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT THE TIP OF AN AR-9300RBT BURR BROKE OFF DURING USE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ALL BROKEN FRAGMENTS WERE REMOVED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 3/4/24: THE PROCEDURE PERFORMED WAS A CM JOINT REPAIR. AN AR-9300RBT WAS USED TO COMPLETE THE CASE. NO CASE DELAY, NO ADDITIONAL ANESTHESIA ADMINISTERED.
Patient problems: Insufficient Information
MAUDE report 18867865 ↗
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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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