Arthrex® AR-1665BCSL-39Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867367272), received between Mar 7, 2022 and Jan 7, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Break

  ON 15-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1665BCSL-39 3.9 BC LOOP 'N' TACK TENODESIS IMPLANT SYSTEM EXPERIENCED AN ISSUE DURING INSERTION. WHEN THE SURGEON ADVANCED THE ANCHOR THROUGH THE PASSPORT CANNULA TO THE BONE, THE EYELET HAD BROKEN OFF FROM THE THREADS OF THE INSERTER. THE EYELET AND ANCHOR WERE PROMPTLY REMOVED FROM THE PATIENT. A 4.75 MM SWIVELOCK ANCHOR WAS THEN OPENED, AND THE SITE WAS RE-PUNCHED WITHOUT ISSUES. THE CASE WAS DELAYED TWO MINUTES FROM THE SURGICAL TIME. THIS WAS DISCOVERED DURING A SLAP REPAIR WITH A BICEPS TENODESIS PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 22-DEC-2025: AN ADDITIONAL TWO MINUTES OF ANESTHESIA WERE ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED IN RELATION TO THE EVENT. THE SURGICAL TECHNICIAN CONFIRMED THAT ALL COMPONENTS WERE RETRIEVED FROM THE PATIENT, AS THE FULL LENGTH OF THE INSERTER THREADS AND A COMPLETE ANCHOR EYELET WERE IDENTIFIED. ALL FRAGMENTS WERE ACCOUNTED FOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988327 ↗
• MalfunctionDec 23, 2025Break; Break

  ON 12/02/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1665BCSL-39 LOOP AND TAC TENDONESIS EYELET BROKE OFF WHEN BEING PLACED INTO THE CANNULA. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO DELAY TO CASE. CASE WAS COMPLETED USING ANOTHER ANCHOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876409 ↗
• MalfunctionJun 27, 2025Break; Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA SEMS-06917603 THAT AN AR-1665BCSL-39 3.9 BC LOOP 'N' TACK¿ TENODESIS IMPLANT SYSTEMS ANCHOR BROKE DURING INSERTION. THIS OCCURRED DURING USE IN A ROTATOR CUFF REPAIR. THE BONE WAS HARD; IT WAS PREPPED WITH THE PUNCH, AND NO PIECES WERE LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22349608 ↗
• MalfunctionFeb 21, 2025Break; Break

  ON 02/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1665BCSL-39 3.9 BC LOOP ¿N¿ TACK TENODESIS IMPLANT SYSTEM HAD AN ISSUE WITH THE EYELET BREAKING OFF THE TIP OF THE 3.9 MM BIOCOMPOSITE SWIVELOCK ANCHOR. THE ANCHOR WAS NOT USED AND A NEW ANCHOR WAS OPENED. THIS WAS DISCOVERED DURING A SHOULDER PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21431782 ↗
• MalfunctionApr 18, 2024Break; Break

  ON 03/25/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1665BCSL-39 LOOP N TACK IMPLANT EYELET BROKE OFF WHEN THE ANCHOR WAS BEING PREPARED. CASE COMPLETED USING A 3.9 SWIVELLOCK. NO DELAY TO CASE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19140476 ↗
• MalfunctionApr 25, 2022Break

  (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2326BCC BIOCOMPOSITE SWIVELOCK EYELET FELL OFF THE INSERTER AND COULD NOT BE USED. A SECOND AR-2326BCC SWIVELOCK WAS OPENED AND THE ANCHOR BROKE OFF INSIDE THE PATIENT, ALL FRAGMENTS WERE RETRIEVED. AN AR-1665BCSL-39 LOOP-N-TAK WAS OPENED AND THE ANCHOR ALSO BROKE OFF INSIDE THE PATIENT, ALL FRAGMENTS WERE RECEIVED. SURGEON COMPLETED CASE WITH A BIGGER SWIVELOCK ANCHOR. THIS WAS DISCOVERED DURING A SUBSCAPULAR REPAIR (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 14194254 ↗
• MalfunctionMar 7, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY FACILITY REPRESENTATIVE THAT AN AR-1665BCSL-39 ANCHOR BROKE UPON INSERTION. THIS WAS DURING A PROCEDURE ON (B)(6) 2022. THE SURGEON REMOVED THE ANCHOR AND USED A NEW AR-1665BCSL-39 TO COMPLETE THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13684537 ↗