Arthrex® AR-9230AGRecalls & reported problems
Arthrex, Inc. · AVL PRIMARY REAMER, MODULAR, LARGE · 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 00888867350458), received between Jul 24, 2023 and Sep 24, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (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. 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, Blunt1
- Naturally Worn1
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.
MalfunctionSep 24, 2024Dull, Blunt; Dull, Blunt
ON 09/17/2024, A SALES REPRESENTATIVE REPORTED VIA SEMS-06665108 THAT AN AR-9230AG UNIVERS VAULTLOCK AUGMENTED GLENOID PRIMARY REAMER WAS VERY DULL AND NOT EFFECTIVELY REAMING THE BONE. NOTHING BROKE INSIDE THE PATIENT. ANOTHER VLK TRAY WAS OPENED TO USE ANOTHER REAMER TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A TOTAL SHOULDER PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20294611 ↗MalfunctionJul 24, 2023Naturally Worn; Naturally Worn
ON (B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9230AG REAMER IS WORN. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17379172 ↗
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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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