Arthrex® AR-6592-08-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867040595), received between Jan 31, 2018 and Jun 23, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2025, A REPRESENTATIVE REPORTED VIA (B)(4) THAT (2) AR-6592-08-30 ARTHREX® PASSPORT BUTTON CANNULAS AND AN AR-6592-12-30 ARTHREX® PASSPORT BUTTON CANNULA RIPPED UPON FIRST INSERTION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22306688 ↗
• MalfunctionJun 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 05/29/2025, A REPRESENTATIVE REPORTED VIA SEMS-06905162 THAT (2) AR-6592-08-30 ARTHREX® PASSPORT BUTTON CANNULAS AND AN AR-6592-12-30 ARTHREX® PASSPORT BUTTON CANNULA RIPPED UPON FIRST INSERTION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22306676 ↗
• MalfunctionDec 5, 2022Break

  IT WAS REPORTED THAT DURING A KNEE LIGAMENT SURGERY THE UPPER HALO WAS BROKEN. THE BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT. ACCORDING TO THE SURGEON THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15914079 ↗
• InjuryFeb 28, 2022Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY WHILE REMOVING THE CANNULA IT BROKE INSIDE THE PATIENT. THE SURGEON HAD TO MAKE A LARGER INCISION TO RETRIEVE THE BROKEN FRAGMENT. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13619281 ↗
• MalfunctionJun 14, 2021Break

  IT WAS REPORTED THAT THE AR-6592-08-30 WAS USED IN ROTATOR CUFF REPAIR. AT THE END OF THE SURGERY, IT WAS CONFIRMED THAT THE PRODUCT WAS DAMAGED. THE SURGEON SEARCHED IN THE PATIENT¿S BODY, BUT COULD NOT FIND ANY BROKEN PIECES. HE SAID THAT DUE TO CONTINUOUS PERFUSION DURING THE OPERATION, THE BROKEN PIECES MAY HAVE BEEN REMOVED FROM THE BODY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11990378 ↗
• InjuryJul 23, 2018Break; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY/ASAD&RCR PROCEDURE, THE PASSPORT BUTTON CANNULA WAS HIT WITH ANOTHER INSTRUMENT AND A PIECE OF THE CANNULA BROKE OFF. THE FRAGMENT THAT BROKE OFF WAS NOT ABLE TO BE FOUND. THE PATIENT¿S SHOULDER WAS RE-EXAMINED AND STILL, THE MISSING FRAGMENT COULD NOT BE LOCATED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7710760 ↗
• InjuryJan 31, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THAT DURING A CASE, THE SURGEON ATTEMPTED TO INTRODUCE AN ARTHREX PASSPORT BUTTON CANNULA IN THE STANDARD WAY USING A HEMOSTAT. THE DISTAL TIP OF THE CANNULA, THE PART THAT WAS GRASPED WITH THE HEMOSTAT, BROKE OFF OUTSIDE OF THE JOINT. THE INCISION HAD TO BE SLIGHTLY EXTENDED TO RETRIEVE THE BROKEN PIECE AND THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT. FOLLOW-UP INVESTIGATION: FACILITY REPORTER CONFIRMED THAT INFORMATION PREVIOUSLY REPORTED IS CORRECT. PER REPORTER THE SMALLER FRAGMENT PIECE, THAT WAS REMOVED FROM THE PATIENT, WAS DISCARDED IN THE TRASH AT TIME OF PROCEDURE AND WAS NOT BEING RETURNED WITH REMAINING PORTION OF DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7230312 ↗