Arthrex® AR-9508-33Recalls & reported problems
Arthrex, Inc. · Humeral Cup Reamer XS/33 · 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 00888867406681), received between Jun 5, 2024 and Jun 5, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (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
- Dull, Blunt2
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.
MalfunctionJun 5, 2024Dull, Blunt; Dull, Blunt
ON 05/08/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9508-33 HUMERAL CUP REAMER WAS DULL AND DID NOT REAM AWAY THE BONE SUFFICIENTLY FROM THEIR HUMERAL 2 TRAY. THE CASE WAS COMPLETED USING A BACKUP TRAY WITH NO ISSUES. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER PROCEDURE, WITH NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 5/13/2024: THIS OCCURRED ON (B)(6) 2024 DURING REVERSE TOTAL SHOULDER PROCEDURE. THERE WAS NO DELAY IN THE CASE OTHER THAN OPENING ANOTHER TRAY. THE AR-9508-33 HUMERAL CUP REAMER DID NOT BREAK, BUT WAS WORN AND DID NOT WORK AS INTENDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19473450 ↗MalfunctionJun 5, 2024Dull, Blunt; Dull, Blunt
ON 05/08/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(3) THAT AN AR-9508-33 HUMERAL CUP REAMER WAS DULL AND DID NOT REAM AWAY THE BONE SUFFICIENTLY FROM THEIR HUMERAL 2 TRAY. THE CASE WAS COMPLETED USING A BACKUP TRAY WITH NO ISSUES. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER PROCEDURE WITH NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 5/13/2024: THIS OCCURRED ON (B)(6) 2024 DURING REVERSE TOTAL SHOULDER PROCEDURE. THERE WAS NO DELAY IN THE CASE OTHER THAN OPENING ANOTHER TRAY. THE AR-9508-33 HUMERAL CUP REAMER DID NOT BREAK, BUT WAS WORN AND DID NOT WORK AS INTENDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19467048 ↗
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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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