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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867358683), received between Dec 27, 2023 and Jun 10, 2024 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2024Break; Break

  ON 12/1/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3636 KNOTLESS FIBERTAK INSERTER BROKE OFF DURING INSERTION. ALL FRAGMENTS WERE RETRIEVED, AND CASE WAS COMPLETED WITH ANOTHER ARTHREX ANCHOR. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. AN ADDITIONAL 20 MINUTES WERE ADDED TO THE CASE DUE TO DEVICE BREAKING. ADDITIONAL INFORMATION RECEIVED ON 12/1/2022: A TOTAL OF (2) AR-3636 KNOTLESS FIBERTAK INSERTERS BROKE INSIDE THE PATIENT AND ALL FRAGMENTS WERE RETRIEVED. DUE TO THE CASE BEING DELAYED FOR 20 MINUTES, ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. ALSO, SURGEON HAD DIFFICULTY INSERTING THE ANCHOR THROUGH THE DRILL SLEEVE OF AN AR-3610ND-2 FLEXIBLE 1.8MM DRILL, AN AR-3610CTC CURVED FIBERTAK SPEAR, AND (2) AR-3610CTC-2 TIGHT CURVED FIBERTAK SPEAR. THIS WAS DISCOVERED DURING A LABRAL REPAIR PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19499288 ↗
• MalfunctionDec 27, 2023Break; Break

  IT WAS REPORTED THAT DURING A LABRUM STABILISATION SURGERY WITH FIBERTAK THE TIP OF THE DRILL BROKE OFF OUTSIDE THE PATIENT. 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 18402816 ↗