Arthrex® AR-2600FSB-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867429857), received between Sep 10, 2024 and Oct 28, 2025 — classified as 3 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. 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.

• MalfunctionOct 28, 2025Material Frayed; Material Frayed

  ON 10/10/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-2600FSB-1 FIBERTAK® SPEEDBRIDGE¿ IMPLANT SYSTEMS SUTURES BEGAN TO FRAY. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2025 WHEN THE SUTURE ON THE FIBERTAK ANCHOR WAS PASSED THROUGH THE ROTATOR CUFF. THE SURGEON BEGAN TO TENSION AND WHEN THE TENSION WAS PLACED ON THE SUTURES, THEY BEGAN TO FRAY. THE DEVICE WAS STILL USED IN THIS PROCEDURE, AND THE ANCHOR WAS SECURED. THERE WAS NO MAJOR DELAY DURING THIS EVENT, AND NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS PROVIDED ON 10/10/2025 WHERE IT WAS REPORTED THAT AN AR-3650DS WAS USED TO PREPARE THE BONE SOCKET FOR INSERTION OF THE IMPLANT. THE SURGEON USED THE DRILL GUIDE TO GET HIS LOCATION ON THE ARTICULAR MARGIN AND DRILLED WITH THE 2.6 DRILL BIT. THE PATIENT HAD GOOD BONE QUALITY AND ALL THREE 2.6 FIBERTAK ANCHORS WERE INSERTED CORRECTLY AND SET WELL AGAINST THE CORTICAL BONE. IT APPEARED THAT SUTURE FRAGMENTS ENTERED THE PATIENT. HOWEVER, THE SURGEON USED A SHAVER AND GRASPER TO RETRIEVE, AND IT APPEARS THAT THE FRAYED SUTURES WERE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23404111 ↗
• MalfunctionAug 15, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 08/14/2025: SPECIFICALLY, THE 4.75 MM KNOTLESS BIOCOMPOSITE SWIVELOCK SP ANCHOR FROM THE AR-2600FSB-1 FIBERTAK SPEEDBRIDGE IMPLANT SYSTEM BROKE DURING THE PROCEDURE. THE CASE WAS COMPLETED USING ADDITIONAL READILY AVAILABLE IMPLANTS, RESULTING IN NO DELAY IN CASE PROGRESSION OR COMPLETION. THERE WAS NO REPORT OF ADDITIONAL ANESTHESIA ADMINISTERED. THE PART NUMBER OF THE IMPLANT USED TO COMPLETE THE CASE IS UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815941 ↗
• MalfunctionSep 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 08/20/2024, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-2600FSB-1 FIBERTAK SPEEDBRIDGE IMPLANT SYSTEM, WHILE USING THE AR-3650DS DISPOSABLES KIT FOR 2.6 FIBERTAK, HAD AN ISSUE WITH TWO OUT OF THE THREE 2.6 FIBERTAK RC SELF-PUNCHING SOFT ANCHORS RIPPING AND PULLING OUT AND NEVER FULLY SETTING UPON IMPLANTING. THE CASE WAS COMPLETED USING A 4.75 SWIVELOCK. THERE WAS UNDER 15 MINUTES OF DELAY IN REMOVING THE TWO SUTURE ANCHORS THAT HAD RIPPED. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20180566 ↗