Arthrex® AR-3637Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867459403), received between Oct 30, 2025 and Feb 11, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Break

  ON 23-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-3637 1.8 KNOTLESS FIBERTAK CONVERSION SUTURE SETS BROKE. THIS WAS DISCOVERED DURING A SHOULDER SCOPE WITH A LABRAL REPAIR PROCEDURE ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 30-JAN-2026: DURING THE PROCEDURE, ISSUES WERE ENCOUNTERED WITH FOUR AR-3637 1.8 KNOTLESS FIBERTAK KITS. IN TWO OF THE KITS, ONE REPAIR SUTURE FROM ONE ANCHOR IN EACH KIT BROKE WHILE THE SURGEON ATTEMPTED TO SHUTTLE THE SUTURE THROUGH THE KNOTLESS MECHANISM. IN THE REMAINING TWO KITS, TWO REPAIR SUTURES FROM TWO ANCHORS BROKE IN THE SAME MANNER. ALL ANCHORS REMAINED IN PLACE, AND ALL SUTURE FRAGMENTS WERE RETRIEVED. THE CASE WAS COMPLETED USING AR-2323KBCC 4.75 MM KNOTLESS SWIVELOCK ANCHORS IN PLACE OF THE AFFECTED DEVICES. THE EVENT RESULTED IN AN ESTIMATED 5¿10-MINUTE SURGICAL DELAY. IT IS UNKNOWN WHETHER THE PATIENT REQUIRED ADDITIONAL ANESTHESIA.

  Patient problems: Foreign Body In Patient

  MAUDE report 24316437 ↗
• MalfunctionFeb 11, 2026Break

  ON 23-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-3637 1.8 KNOTLESS FIBERTAK CONVERSION SUTURE SETS BROKE. THIS WAS DISCOVERED DURING A SHOULDER SCOPE WITH A LABRAL REPAIR PROCEDURE ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 30-JAN-2026: DURING THE PROCEDURE, ISSUES WERE ENCOUNTERED WITH FOUR AR-3637 1.8 KNOTLESS FIBERTAK KITS. IN TWO OF THE KITS, ONE REPAIR SUTURE FROM ONE ANCHOR IN EACH KIT BROKE WHILE THE SURGEON ATTEMPTED TO SHUTTLE THE SUTURE THROUGH THE KNOTLESS MECHANISM. IN THE REMAINING TWO KITS, TWO REPAIR SUTURES FROM TWO ANCHORS BROKE IN THE SAME MANNER. ALL ANCHORS REMAINED IN PLACE, AND ALL SUTURE FRAGMENTS WERE RETRIEVED. THE CASE WAS COMPLETED USING AR-2323KBCC 4.75 MM KNOTLESS SWIVELOCK ANCHORS IN PLACE OF THE AFFECTED DEVICES. THE EVENT RESULTED IN AN ESTIMATED 5¿10-MINUTE SURGICAL DELAY. IT IS UNKNOWN WHETHER THE PATIENT REQUIRED ADDITIONAL ANESTHESIA.

  Patient problems: Foreign Body In Patient

  MAUDE report 24316387 ↗
• MalfunctionFeb 11, 2026Break

  ON (B)(6) 2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-3637 1.8 KNOTLESS FIBERTAK CONVERSION SUTURE SETS BROKE. THIS WAS DISCOVERED DURING A SHOULDER SCOPE WITH A LABRAL REPAIR PROCEDURE ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 30-JAN-2026: DURING THE PROCEDURE, ISSUES WERE ENCOUNTERED WITH FOUR AR-3637 1.8 KNOTLESS FIBERTAK KITS. IN TWO OF THE KITS, ONE REPAIR SUTURE FROM ONE ANCHOR IN EACH KIT BROKE WHILE THE SURGEON ATTEMPTED TO SHUTTLE THE SUTURE THROUGH THE KNOTLESS MECHANISM. IN THE REMAINING TWO KITS, TWO REPAIR SUTURES FROM TWO ANCHORS BROKE IN THE SAME MANNER. ALL ANCHORS REMAINED IN PLACE, AND ALL SUTURE FRAGMENTS WERE RETRIEVED. THE CASE WAS COMPLETED USING AR-2323KBCC 4.75 MM KNOTLESS SWIVELOCK ANCHORS IN PLACE OF THE AFFECTED DEVICES. THE EVENT RESULTED IN AN ESTIMATED 5¿10-MINUTE SURGICAL DELAY. IT IS UNKNOWN WHETHER THE PATIENT REQUIRED ADDITIONAL ANESTHESIA.

  Patient problems: Foreign Body In Patient

  MAUDE report 24316259 ↗
• MalfunctionFeb 11, 2026Break

  ON 23-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-3637 1.8 KNOTLESS FIBERTAK CONVERSION SUTURE SETS BROKE. THIS WAS DISCOVERED DURING A SHOULDER SCOPE WITH A LABRAL REPAIR PROCEDURE ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 30-JAN-2026: DURING THE PROCEDURE, ISSUES WERE ENCOUNTERED WITH FOUR AR-3637 1.8 KNOTLESS FIBERTAK KITS. IN TWO OF THE KITS, ONE REPAIR SUTURE FROM ONE ANCHOR IN EACH KIT BROKE WHILE THE SURGEON ATTEMPTED TO SHUTTLE THE SUTURE THROUGH THE KNOTLESS MECHANISM. IN THE REMAINING TWO KITS, TWO REPAIR SUTURES FROM TWO ANCHORS BROKE IN THE SAME MANNER. ALL ANCHORS REMAINED IN PLACE, AND ALL SUTURE FRAGMENTS WERE RETRIEVED. THE CASE WAS COMPLETED USING AR-2323KBCC 4.75 MM KNOTLESS SWIVELOCK ANCHORS IN PLACE OF THE AFFECTED DEVICES. THE EVENT RESULTED IN AN ESTIMATED 5¿10-MINUTE SURGICAL DELAY. IT IS UNKNOWN WHETHER THE PATIENT REQUIRED ADDITIONAL ANESTHESIA.

  Patient problems: Foreign Body In Patient

  MAUDE report 24316189 ↗
• MalfunctionOct 30, 2025Break; Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-3637 KNOTLESS 1.8 FIBERTAK IMPLANT SYSTEM'S ANCHOR TIP SNAPPED IN HALF DURING INSERTION. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. AN AR-3636 KNOTLESS 1.8 FIBERTAK SOFT ANCHOR WAS USED TO COMPLETE THE CASE. THERE WAS NO CASE DELAY, AND IT IS UNCERTAIN IF ADDED ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED. THIS WAS DISCOVERED DURING A LABRUM REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425451 ↗