Arthrex® AR-11040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867002692), received between Jul 11, 2022 and Apr 25, 2024 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 25, 2024Difficult to Open or Close; Difficult to Open or Close

  ON 04/02/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-11040 PUNCH CLAMP DOES NOT CLOSE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183364 ↗
• MalfunctionJul 11, 2022Break

  ON 06/22/2022 IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-11040 PUNCH, IS BROKEN. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM REPORTED. REQUESTED ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14976712 ↗