Arthrex® AR-9236-03Recalls & reported problems
Arthrex, Inc. · TRIAL, LARGE, PEGGED GLENOID · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867059498), received between Aug 1, 2022 and Sep 11, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2024Break; Break
ADDITIONAL INFORMATION WAS PROVIDED ON 08/27/2024 WHERE IT WAS STATED THIS EVENT OCCURRED DURING AN ANATOMIC TSA ON (B)(6) 2024. THE CENTRAL PEG FELL OFF WHEN THE TRIAL WAS TAKEN OUT OF THE PATIENT. THE PATIENT HAD A NORMAL BONE QUALITY. THE PROCEDURE CONTINUED AS PER THE TECHNIQUE GUIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20190548 ↗MalfunctionAug 31, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9236-03 PEGGED GLENOIDS CENTRAL PEG IN THE DEVICE BROKE OFF. THIS OCCURRED DURING A PROCEDURE, ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT EFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17662445 ↗MalfunctionAug 1, 2022Break
ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT BOTH AN AR-9236-03PP GLENOID TRIAL AND AN AR-9236-03 PEGGED GLENOID TRIAL BROKE IMMEDIATELY UPON PUSHING INTO THE GLENOID WITH HAND. THIS OCCURRED DURING A TOTAL ECLIPSE TOTAL SHOULDER PROCEDURE. ALL WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A TRIAL BEING USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15137873 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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