Arthrex® AR-9229GRPPRecalls & reported problems
Arthrex, Inc. · UNIVERS VAULTLOCK GLENOID REAMER, MEDIUM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867239081), received between Apr 30, 2024 and Jun 18, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (4 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, Blunt4
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2024Dull, Blunt; Dull, Blunt
IT WAS REPORTED THE AR-9229GRPP, GLENOID REAMER IS DULL.
Patient problems: Insufficient Information
MAUDE report 19560061 ↗MalfunctionJun 13, 2024Dull, Blunt; Dull, Blunt
IT WAS REPORTED THAT THE REAMER IS DULL.
Patient problems: Insufficient Information
MAUDE report 19531520 ↗MalfunctionApr 30, 2024Dull, Blunt; Dull, Blunt
ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THE SURGEON WAS USING THE AR-9229GRPP ATTEMPTING TO REAM THE GLENOID, THE REAMER WAS DULL. THE SURGEON REMOVED THE REAMER FROM THE JOINT AND CLEAN IT OFF, THEN REAPPLY WITH MORE FORCE THAN SHOULD BE REQUIRED. AFTER DOING THIS MULTIPLE TIMES WE WERE ABLE TO GET A PREPPED SURFACE FOR OUR IMPLANT. THIS WAS DISCOVERED DURING USE IN A TSA PROCEDURE ON (B)(6) 2022. NO PATIENT AFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19215637 ↗MalfunctionApr 30, 2024Dull, Blunt; Dull, Blunt
ON 10/20/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT THE FOLLOWING REAMERS WERE FOUND TO BE DULL: AR-9288GRPP, AR-9229GRPP, AR-9230GRPP AND AR-9231GRPP. THE SURGEON USED ALL REAMERS, FROM SMALLEST (AR-9288GRPP) TO LARGEST (AR-9231GRPP) UNTIL THE DEPTH DESIRED FOR EACH WAS REACHED. AFTER COMPLETION WITH THE EXTRA-LARGE REAMER, THE SURGEON WENT BACK TO THE SMALL REAMER AND BEGAN TO REAM THE INSERTION SITE. DURING REAMING THE SURGEON USED FORCE ON THE SMALL REAMER CAUSING THE DEVICE TO REAM MORE THAN THE DESIRED DEPTH ON THE GLENOID. THIS PORTION OF THE PROCEDURE WAS COMPLETED USING EXTRA CEMENT TO ACHIEVE GOOD FIXATION
Patient problems: Insufficient Information
MAUDE report 19212193 ↗
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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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