Arthrex® AR-8908DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867351578), received between Jun 10, 2024 and Mar 25, 2026 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Material Twisted/Bent

  ON 05-MAR-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8908DS KNOTLESS MINI TIGHTROPE IMPLANT SYSTEM HAD THE SUTURE NOT TENSION NORMALLY. THIS WAS DISCOVERED DURING A LISFRANC ORIF PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 11-MAR-2026: THE PROBLEM WAS IDENTIFIED INSIDE THE PATIENT WHEN THE TIGHTROPE DEVICE WAS TIGHTENED. AS TENSION WAS APPLIED, THE DEVICE BUNCHED UP ON ONE OF THE STRANDS, RESULTING IN UNEVEN TENSION AND PREVENTING THE CONSTRUCT FROM FULLY TIGHTENING. THE SUTURE BECAME DAMAGED AS A DIRECT RESULT OF THE ISSUE. THE AFFECTED IMPLANT WAS REMOVED, AND THE CASE WAS COMPLETED USING A SECOND AR-8908DS DEVICE. THE EVENT CAUSED ONLY A BRIEF DELAY OF A FEW MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING OR FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689668 ↗
• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE KNOT UNTIED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A 4 MM CANNULATED SCREW. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21305636 ↗
• MalfunctionJun 10, 2024Break; Break

  ON 11/21/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8908DS KNOTLESS MINI TIGHTROPE FEEDLINE BROKE. SURGEON WAS ABLE TO REMOVE IT BACKWARDS AND OPEN A NEW ONE TO COMPLETE THE CASE WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A LIS FRANC PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 11/22/2022: CASE WAS COMPLETED USING ANOTHER AR-8908DS KNOTLESS MINI TIGHTROPE FROM THE SAME LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19499204 ↗