Arthrex® AR-2600FSB-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867429864), received between Mar 20, 2025 and Nov 13, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 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.

• MalfunctionNov 13, 2025Break; Break

  ON 10/17/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE AR-7535 FIBERLINK 1.3 MM SUTURE TAPE COMPONENT IN THE AR-1665BCSL 4.75 MM BIOCOMPOSITE LOOP 'N' TACK TENODESIS IMPLANT SYSTEM WAS USED DURING A PROCEDURE. WHILE PASSING THE AR-7535 SUTURE USING THE PURPLE DISPOSABLE INSTRUMENT INCLUDED IN THE KIT, A PORTION OF THE RETRACTABLE JAW BROKE OFF INSIDE THE PATIENT. NO FOREIGN BODIES REMAINED IN THE PATIENT AFTER THE ISSUE. THE INSTRUMENT WAS FULLY INTACT UPON OPENING. AFTER GRASPING THE SUTURE AND CLOSING THE JAW TO PULL IT THROUGH THE BICEPS, THE SUTURE WAS RELEASED. UPON ATTEMPTING TO RELOAD THE SUTURE, IT WAS OBSERVED THAT APPROXIMATELY 2 MM OF THE LOWER RETRACTABLE JAW WAS MISSING. ADDITIONALLY, DURING USE OF THE AR-2600FSB-2 KNOTLESS FIBERTAK SPEEDBRIDGE IMPLANT SYSTEM, THE PACKAGING WAS FOUND TO BE FLIMSY AND PRONE TO TEARING ACROSS THE CENTER RATHER THAN ALONG THE SIDE SEAMS. FURTHERMORE, THE AR-13999HDN NEEDLE COMPONENT WITHIN THE SAME AR-2600FSB-2 KIT BROKE DURING USE. SPECIFICALLY, THE NEEDLE TIP BROKE OFF AROUND THE (B)(6) PASS WHILE SUTURING THROUGH THE ROTATOR CUFF. AN X-RAY CONFIRMED THAT NO FOREIGN BODIES REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544188 ↗
• MalfunctionJun 18, 2025Positioning Failure; Positioning Failure

  ON 05/22/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-2600FSB-2 SPEEDBRIDGE FAILED TO DEPLOY. AND AN AR-4580 FIBERSTITCH DID NOT PUNCH AND THE MECHANISM BALLED UP AND FAILED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282450 ↗
• MalfunctionMar 20, 2025Break; Break

  ON 3/5/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE EYELET OF A SELF-PUNCHING SWIVELOCK FROM AN AR-2600FSB-2 KNOTLESS FIBERTAK SPEEDBRIDGE IMPLANT SYSTEM BROKE DURING INSERTION. ANOTHER ANCHOR WAS OPENED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652594 ↗