Arthrex® AR-9216AGRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867350427), received between Apr 25, 2023 and Dec 17, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9216AG CENTRAL DRILL'S PIN CAME OUT WITH THE DRILL, APPEARS ALMOST FUSED TOGETHER. THE ISSUE OCCURRED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826621 ↗
• MalfunctionApr 25, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS, THAT AN AR-9216AG UNIVERS VAULTLOCK® AUGMENTED GLENOID 6 MM CANNULATED CENTRAL DRILL BROKE OFF. WITH NO FURTHER DETAILS. THIS WAS DISCOVERED, DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809160 ↗