Arthrex® AR-12540Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867006461), received between Jul 10, 2019 and Mar 27, 2023 — classified as 1 injury, 2 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.

• MalfunctionMar 27, 2023Break; Break

  ON 03/09/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-12540 SUTURE RETRIEVER BROKE. THIS OCCURRED DURING AN ARTHROSCOPIC REPAIR OF THE LEFT ROTATOR CUFF ON 03/07/2023 WHEN IT WAS NOTICED THAT THE FRONT END OF THE DEVICE WAS BROKEN. THE PROCEDURE WAS COMPLETED USING A DEVICE FROM A DIFFERENT MANUFACTURER. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 16618646 ↗
• MalfunctionDec 12, 2022Break; Mechanical Jam

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-12540 SUTURE RETRIEVERS JAW BROKE AND WILL NO LONGER OPEN OR CLOSE. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15960742 ↗
• InjuryJul 10, 2019Break

  IT WAS REPORTED THAT A PART OF THE PLIERS BROKE OFF AND REMAIN INSIDE THE PATIENT. THE PIECE COULD NOT BE FOUND.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8774869 ↗