Arthrex® AR-3610CTC-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867354296), received between Feb 21, 2025 and Mar 18, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Physical Resistance/Sticking

  ON 26-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-3610CTC-2 1.8 KNOTLESS FIBERTAK 30-DEGREE CURVED GUIDE WAS COMPROMISED DURING INSERTION OF A 1.8 KNOTLESS FIBERTAK ANCHOR DURING A SHOULDER INSTABILITY PROCEDURE. GUIDE WAS PLACED INTERARTICULAR, A 1.8MM FLEXIBLE DRILL WAS PLACED DOWN THE GUIDE. THE DRILL WAS USED AND REMOVED, A 1.8 KNOTLESS FIBERTAK ANCHOR WAS PLACED DOWN GUIDE AND INSERTED SUCCESSFULLY, THE SURGEON WENT TO REMOVE THE ANCHOR DRIVER, AND IT WAS COMPLETELY STUCK WITHIN THE GUIDE - THE STABILITY SLEEVE WAS JAMMED IN THE PROXIMAL END OF THE GUIDE WITH NO ABILITY TO REMOVE THE ANCHOR DRIVER. SURGEON CUT THE ANCHOR OUT AND WAS ABLE TO REMOVE THE GUIDE AND ANCHOR DRIVER WITH ANCHOR AND SUTURES STILL HOUSED WITHIN. THE SURGEON USED A NEW ANCHOR AND GUIDE TO INSERT AND COMPLETE THE PROCEDURE. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626900 ↗
• MalfunctionFeb 21, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 01/27/2025, IT WAS REPORTED BY A ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(6) THAT AN AR-3610CTC-2 FIBNERTAK SPEAR AND AN AR-3600 FIBERTAK ANCHOR BECAME STUCK IN THE DRILL GUIDE WHEN THE SURGEON WENT TO INSERT. THIS OCCURRED DURING USE IN AN ARCR CASE WITH NO PATIENT HARM. THIS CASE WAS COMPLETED BY USING ANOTHER PRODUCT OF SAME PRODUCT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21436540 ↗