Arthrex® AR-11794LRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867003590), received between Sep 26, 2022 and Dec 9, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025Fracture; Fracture

  ON 11/21/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-11794L SUTURE CUTTER FRACTURED DURING USE. THIS WAS DISCOVERED DURING INTRA-ARTICULAR MANIPULATION WITH NO PATIENT HARM. THE ENTIRE ITEM WAS REMOVED WITHOUT LEAVING ANY FRAGMENTS INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757837 ↗
• MalfunctionJun 11, 2024Break; Break

  ON 05/15/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-11794L SUTURE CUTTER BROKE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. A NEW SUTURE CUTTER WAS USED TO COMPLETE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509081 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT INTERNAL LINKAGE THAT CONNECTS THE HANDLE TO THE JAW SEEMS TO BE BROKEN/DISCONNECTED.

  Patient problems: Insufficient Information

  MAUDE report 19133438 ↗
• MalfunctionSep 26, 2022Break; Failure to Cut

  ON 09/07/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-11794L SUTURE CUTTER HAD AN ISSUE. DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2022, THE SUTURE CUTTER WAS BROKEN SUDDENLY, IT COULD NOT CUT ANYMORE. THE PIECE BROKE OFF INSIDE THE PATIENT, THE FRAGMENT WAS RETRIEVED FROM THE PATIENT AND THERE WAS NO HARM TO THE PATIENT. THE SURGEON USED ANOTHER NEW PRODUCT WITH THE SAME TYPE AND LOT NUMBER TO COMPLETE THE PROCEDURE SUCCESSFULLY, NO SECOND OPERATION WAS NEEDED. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15484223 ↗