Arthrex® AR-1665BCSLRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867367265), received between Mar 28, 2022 and Nov 13, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 8 most recent of 8 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 (SEE ATTACHED PHOTO). 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 (SEE ATTACHED PHOTO). FURTHERMORE, THE AR-13999HDN NEEDLE COMPONENT WITHIN THE SAME AR-2600FSB-2 KIT BROKE DURING USE. SPECIFICALLY, THE NEEDLE TIP BROKE OFF AROUND THE 12TH OR 13TH PASS WHILE SUTURING THROUGH THE ROTATOR CUFF (SEE ATTACHED PHOTO). AN X-RAY CONFIRMED THAT NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544190 ↗
• MalfunctionJun 17, 2025Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  ON 05/09/2025, A REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-1665BCSL 4.75 BC LOOP 'N' TACK¿ TENODESIS IMPLANT SYSTEM BROKE OFF DURING SUTURE PASSAGE. THIS OCCURRED DURING A ROTATOR CUFF REPAIR. WHEN THE RETRACTABLE TIP GOT STUCK ON THE SCOPE SHEATH, IT BROKE OFF WHEN TRYING TO REMOVE IT.

  Patient problems: Insufficient Information

  MAUDE report 22236757 ↗
• MalfunctionMay 28, 2025Break; Break

  ON 05/09/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-1665BCSL 4.75 BC LOOP 'N' TACK¿ TENODESIS IMPLANT SYSTEMS TIP BROKE OFF. THIS OCCURRED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22098830 ↗
• MalfunctionJun 10, 2024Separation Problem; Separation Problem

  ON 12/14/2021, IT WAS REPORTED BY SALES REPRESENTATIVE VIA EMAIL THAT THE PUNCH HANDLE, FROM AN AR-1665BCSL SWIVELOCK IMPLANT SYSTEM, SPUN AND WOULDN'T PULL OUT FROM BONE AFTER SURGEON TAPPED IT WITH A MALLET TO CREATE BONE HOLE. THIS WAS DISCOVERED DURING A PROCEDURE. SURGEON HAD TO USE PLIERS AND MALLET THE PUNCH OUT. AFTER RECEIVING ADDITIONAL INFORMATION ON 12/15/2021, SALES REPRESENTATIVE HAS CONFIRMED THAT THIS OCCURRED DURING AN RCR PROCEDURE. NOTHING BROKE INSIDE THE PATIENT AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505545 ↗
• MalfunctionJun 4, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED ON 09/14/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1665BCSL IMPLANT SYSTEM KIT PUNCH HANDLE IS LOOSE AND IS HARD TO REMOVE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19462380 ↗
• MalfunctionMay 15, 2024Break; Break

  ON 02/09/2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-1665BCSL LNT IMPLANT SYSTEM, 4.75 BC SWIVELOCK COMPLETELY BROKE OFF FROM THE ATTACHED HANDLE DURING A SURGICAL CASE ON (B)(6) 2022. THERE WAS NO HARM TO THE PATIENT, NO PIECES BROKE OFF INSIDE THE PATIENT, AND THE SURGICAL CASE WAS COMPLETED AS PLANNED. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED. ON 02/15/2022, THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE PROCEDURE WAS A RIGHT SHOULDER ARTHROSCOPY BICEPS TENODESIS. THE DEVICE DID NOT BREAK INSIDE THE PATIENT, THE DEVICE BROKE WHILE USING IT, LEAVING THE METAL TIP STICKING OUT OF THE PATIENT. NOTHING WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED, NO HARM TO THE PATIENT, NO IMPACT, A POSSIBLE 5 MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19327238 ↗
• MalfunctionMay 7, 2024Component Misassembled; Component Misassembled

  ON 04/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1665BCSL LNT IMPLANT SYSTEM WAS MANUFACTURED BACKWARDS, CAUSING BAR TO FACE UP INSTEAD OF DOWN, LEADING TO BREAKAGE AND DIFFICULTY PASSING SUTURE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19261462 ↗
• MalfunctionMar 28, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1665BCSL LNT IMPLANT SYSTEM 4.75 SWIVELOCK EYELET BROKE OFF WHILE PASSING THE SUTURE THROUGH THE EYELET. THIS WAS DISCOVERED DURING AN ACL PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 13928994 ↗