Arthrex® AR-6562Recalls & reported problems
Arthrex, Inc. · CRYSTAL CANNULA, SMOOTH · Class 1
Data updated Oct 13, 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 00888867040311), received between May 4, 2022 and May 16, 2024 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Contamination1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2024Contamination; Contamination
IT WAS REPORTED THAT THERE IS A HAIR IN THE SEALED PACKAGE.
Patient problems: Insufficient Information
MAUDE report 19332179 ↗MalfunctionMay 4, 2022Break
ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-6562 CRYSTAL CANNULA BROKE DURING A SLAP DEBRIDEMENT WITH A BICEPS TENODESIS PROCEDURE. THE DAM ON THE CRYSTAL CANNULA BROKE RESULTING IN ALL PIECES OF THE DAM FALLING INSIDE THE PATIENTS JOINT SPACE. THIS WAS NOT DISCOVERED UNTIL OPERATING THE SHAVER INSIDE THE JOINT. THE PIECES OF THE DAM WERE NOTICED AND ALL WERE RETRIEVED. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14281651 ↗
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- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
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- MITEK 242025Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC61 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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