Arthrex® AR-6500RBDRecalls & reported problems
Arthrex, Inc. · Burr, Round, HL, DiamondCut, 5.0mmx19cm · Class 1
Data updated Oct 18, 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 00888867525726), received between Feb 11, 2026 and Feb 11, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2026Material Fragmentation
ON 23-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6500RBD ROUND BURR HAD METAL SHARDS FLAKING OFF THE DISTAL END OF THE BURR WHEN THEY WERE SMOOTHING OUT SOME BONE. IT WAS VISIBLE ON THE SURROUNDING SOFT TISSUE. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED WITH ANOTHER BURR. ADDITIONAL INFORMATION PROVIDED 02-FEB-2026: IT WAS FURTHER REPORTED THIS WAS DISCOVERED DURING A HIP ARTHROSCOPY PROCEDURE WITH A MINIMAL DELAY EXPERIENCED AND NO ADDITIONAL ANESTHESIA ADMINISTERED. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24315413 ↗
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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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