Arthrex® AR-1934BCF-24-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867023918), received between Mar 8, 2021 and Sep 15, 2026 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Device Dislodged or Dislocated

  On 1st September 2026, it was reported by an Arthrex's employee via an Email that for 1 unit of AR-1934BCF-24-2, 2.4 mm BioComposite SutureTak® Suture Anchor with one #2 FiberWire® and one #2 TigerWire®, its anchor pulled out during insertion.This was detected during a labial repair surgery on (b)(6) 2026. The procedure was completed successfully by using another new AR-1934BCF-2. There were no patient harm and no secondary procedure needed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772857 ↗
• MalfunctionJul 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON(B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1934BCF-24-2 BIOCOMPOSITE SUTURETAK ANCHOR PULLED OUT OF THE IMPLANTATION SITE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED USING A NEW PRODUCT. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: THIS WAS DISCOVERED DURING A LABRAL REPAIR PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 17417785 ↗
• MalfunctionMay 3, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1934BCF-24-2 BIO-COMPOSITE SUTURETAK BROKE DURING INSERTION. ANOTHER ONE WAS USED AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING AN ARTHROSCOPIC BANKART REPAIR ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14270352 ↗
• MalfunctionMar 7, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1934BCF-24-2 SUTURETAK CAME OFF DURING USE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED (B)(6) 2022: THIS WAS DISCOVERED DURING A LABRAL REPAIR PROCEDURE. THE SUTURETAK ANCHOR BROKE OFF INSIDE THE PATIENT AND ALL FRAGMENTS WERE RETRIEVED. CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES USING AN AR-1934BCF-24-2 BIOCOMPOSITE SUTURETAK.

  Patient problems: Insufficient Information

  MAUDE report 13684822 ↗
• MalfunctionFeb 28, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1934BCF-24-2 SUTURE TAK ANCHOR BROKE OFF DURING INSERTION. SURGEON REMOVED ALL THE SUTURES BUT THE ANCHOR REMAINS IN THE PATIENT. ANOTHER AR-1934BCF-24-2 SUTURE TAK FROM THE SAME LOT NUMBER WAS OPENED AND SURGEON MADE SURE TO DOUBLE DRILL BEFORE IMPLANTING THE ANCHOR. CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13620085 ↗
• MalfunctionMar 8, 2021Device Slipped

  IT WAS REPORTED, THAT DURING A SHOULDER LABRAL REPAIR PROCEDURE THE SURGEON PREDRILLED USING THE 2.4 DRILL AND GUIDE. THE SURGEON INSERTED AND SEATED THE AR-1934BCF-24-2 ANCHOR. THE SURGEON PULLED TO TIGHTEN THE SUTURES AND THE SUTURES CAME THROUGH THE AR-1934BCF-24-2. THE CASE WAS COMPLETED THE SURGEON RE-DRILLED THROUGH THE 1ST AR-1934BCF-24-2 ANCHOR AND INSERTED SEATED A SECOND AR-19934BCF-24-2 OVER IT.

  Patient problems: Insufficient Information

  MAUDE report 11436599 ↗