Arthrex® AR-6592-06-30Recalls & reported problems
Arthrex, Inc. · PASSPORT BUTTON CANNULA · Class 1
Data updated Oct 16, 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 00888867040557), received between Oct 18, 2023 and Jun 5, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
Patient problems
- Foreign Body In Patient1
- 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.
MalfunctionJun 5, 2024Break; Break
IT WAS REPORTED ON 07/29/2022 BY A ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-6592-06-30 PASSPORT CANNULA HAS TORN FINS. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19472737 ↗MalfunctionOct 18, 2023Break; Break
ON 9/20/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-6592-06-30 PASSPORT BUTTON CANNULA HAD AN ISSUE. THE CANNULA INSERTION PART BROKE DURING USE IN AN UNSPECIFIED PROCEDURE ON (B)(6) 2023. NO PIECE BROKE OFF INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 10/2/2023, THE ARTHREX SUBSIDIARY EMPLOYEE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS OCCURRED DURING A MENISCAL REPAIR PROCEDURE. THE COMPLAINT DEVICE BROKE DURING SURGERY INSIDE THE PATIENT. THE SURGEON COULD NOT RETRIEVE ALL FRAGMENTS, AND PART OF THE PRODUCT REMAINED IN THE PATIENT. A NEW AR-6592-06-30 PASSPORT BUTTON CANNULA WITH AN UNKNOWN LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE. THE COMPLAINT DEVICE WAS AVAILABLE FOR RETURN.
Patient problems: Foreign Body In Patient
MAUDE report 17958035 ↗
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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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