Arthrex® AR-11800Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867003637), received between Aug 24, 2023 and Feb 16, 2026 — 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Break

  ON 28-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-11800 BIRDBEAK TIP WAS BROKEN OFF. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344609 ↗
• MalfunctionDec 1, 2023Break; Break

  ON 11/01/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-06072628 THAT AN AR-11800 BIRDBEAK BROKE. THIS OCCURRED DURING A CASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18248365 ↗
• MalfunctionAug 24, 2023Break; Break

  IT WAS REPORTED THAT THE TIP AT THE FRONT PART BROKE OFF INTRAOPERATIVELY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. UPDATE SWIT (B)(6) 2023: A LABRUM REFIXATION SURGERY WAS PERFORMED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A LASSO. THE DEVICE BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17611230 ↗