Arthrex® AR-6549QRecalls & reported problems
Arthrex, Inc. · Obturator for AR-6550, AR-6567, AR-6570 · 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 00888867402768), received between Sep 7, 2023 and Nov 21, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2023Failure to Advance; Failure to Advance
ON 10/25/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6549Q OBTURATOR WOULD NOT FIT DOWN THE COMMUTATION OF 7X7 CANNULA AND WOULD STOP AROUND 2/3 WAY DOWN. THE DEVICE WAS TRIED ON SEVERAL CANNULAS. THIS WAS DISCOVERED DURING A ROTATOR CUFF PROCEDURE. THE CASE WAS COMPLETED BY USING A NEW DEVICE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18182304 ↗MalfunctionSep 7, 2023Failure to Advance; Failure to Advance
ON 8/8/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-6549Q OBTURATOR HAD AN ISSUE. WHEN PART NUMBER AR-6549Q WAS PLACED ON THE BLACK ATTACHMENT HANDLE, THE SWITCHING STICK DIDN'T PASS THROUGH. BY ITSELF, IT WORKED OKAY. WHEN ALL OTHER OBTURATORS WERE LOADED ONTO THE BLACK HANDLE, THE SWITCHING STICK PASSED OKAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES WITH THE PATIENT. THIS OCCURRED DURING USE IN AN UNSPECIFIED PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 8/24/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS OCCURRED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023. THE COMPLAINT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PIECE OF THE INSTRUMENT BROKE INSIDE THE PATIENT, AND THERE WAS NO CASE DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17699505 ↗
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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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