Arthrex® AR-12140Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867005181), received between Oct 4, 2021 and Nov 26, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (2 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.

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.

• MalfunctionNov 26, 2025Break; Difficult to Open or Close; Break; Difficult to Open or Close

  ON 11/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-12140 SCISSORS WERE BROKEN. THE PUSH/PULL ROD INSIDE THE SHAFT WAS BROKEN AND THE TOP JAW DID NOT CLOSE ANYMORE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656181 ↗
• MalfunctionOct 4, 2021Difficult to Open or Close

  ON 09/14/2021, IT WAS REPORTED DURING A MAUDE REVIEW, THAT WHEN THE SURGEON INSERTED AN AR-12140 SCISSORS INTO THE PATIENT'S SHOULDER AND THE DEVICE WAS OPENED, THE AR-12140 WOULD NOT CLOSE. THIS WAS DISCOVERED DURING USE IN A SHOULDER ARTHROSCOPY ON (B)(6) 2021. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE CASE WAS COMPLETED WITH A NEW AR-12140.

  Patient problems: Insufficient Information

  MAUDE report 12569286 ↗