Arthrex® AR-3610CTCRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867354265), received between Nov 10, 2023 and Sep 23, 2026 — classified as 5 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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during the shoulder stabilization surgery, the repair suture of two AR-3636 snapped after they had been placed using the placement instrument AR-3610CTC. As a result, the placement instrument AR-3610CTC was replaced, and the remaining new AR-3636 implants were successfully placed. Per complaint reporter there was no harm for patient, operator or third party. The surgery was finished successfully with a new device with the same part number. It was not necessary to switch the surgical technique or do a second surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869628 ↗
• MalfunctionApr 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY SURGERY THE CURVED GUIDE FOR THE FIBERTAK BECAME OBSTRUCTED WITH THE IMPLANT INSIDE, WHICH HAD FRACTURED. DESPITE MULTIPLE ATTEMPTS, INCLUDING HIGH-PRESSURE IRRIGATION, LUBRICANT, AND OTHER AGENTS, IT COULD NOT BE REMOVED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 25021481 ↗
• MalfunctionDec 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A LABRUM FIX WITH FIBER TAK 1.8MM SURGERY THE ANCHOR COULD NOT BE INSERTED FROM THE DRILL SLEEVE AND DID BREAK OFF. THE PIECE DID NOT BREAK OFF INSIDE THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE AND PUSHLOCK REFIX SURGICAL TECHNIQUE. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21039678 ↗
• MalfunctionMar 29, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ROTATOR CUFF REPAIR SURGERY THE TEETH OF THE SETTING TOOL BENT/BROKE OFF. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002774 ↗
• MalfunctionNov 10, 2023Material Twisted/Bent; Material Twisted/Bent

  ON 10/17/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3610CTC CURVED FIBERTAKS DRILL GUIDE WAS BENT. THIS OCCURRED DURING A PROCEDURE; THE 1.8 KNOTLESS FIBERTAK WAS INSERTED IN A STANDARD FASHION USING THE REUSABLE CURVED DRILL GUIDE. AFTER THE INSERTION OF THE ANCHOR, THE GUIDE WAS REMOVED, AND IT WAS NOTICED THAT ONE OF THE TIPS ON THE CROWN OF THE GUIDE WAS BENT. THIS WAS NOT NOTICEABLE AT THE BEGINNING OF THE CASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18113199 ↗