Arthrex® AR-6564Recalls & reported problems
Arthrex, Inc. · CRYSTAL CANNULA, PARTIALLY THREADED · 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 00888867040342), received between Aug 22, 2025 and Aug 22, 2025 — 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
- 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.
MalfunctionAug 22, 2025Break; Break
ON 8/4/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-6564 PARTIALLY THREADED CANNULA FRACTURED AT THE TIP DURING USE IN A PATIENT¿S SHOULDER, RESULTING IN A SMALL FRAGMENT BREAKING OFF. THE SURGEON SUCCESSFULLY RETRIEVED AND SUCTIONED OUT THE FRAGMENT WITHOUT FURTHER COMPLICATIONS. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS PROVIDED ON 08/08/2025: THIS WAS DISCOVERED DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2025. THE CASE WAS COMPLETED USING A REPLACEMENT AR-6564 PARTIALLY THREADED CANNULA. THERE WAS NO CASE DELAY OR ADDED ANESTHESIA ADMINISTERED TO THE PATIENT. THERE WERE NO PHOTOS TAKEN OF THIS EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22872436 ↗
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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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