Arthrex® AR-8958TDSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867249790), received between Apr 3, 2024 and Apr 29, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (1 report).

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.

• MalfunctionApr 29, 2024Defective Device; Defective Device

  ON 03/17/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8958TDS DUAL TIGHTROPE SYNDESMOSIS IMPLANT SYSTEM, WHILE TENSIONING DOWN THE SECOND TIGHTROPE FROM THE KIT ONE OF THE SUTURES OF THE LOOPS AS IT WAS GOING THROUGH THE BUTTON WAS BUNCHING UP AND WOULDN'T TIGHTEN. UPON FURTHER AND CLOSER EXAMINATION THE SURGEON DETERMINED THAT ONE OF THE FOUR HOLES LOCATED ON THE PLATE SIDE BUTTON DID NOT HAVE ANY SUTURE GOING THROUGH IT. THE TIGHTROPE WAS CUT OUT AND A NEW TIGHTROPE WAS OPENED TO REPLACE. CASE WAS COMPLETE WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A SYNDESMOSIS REPAIR PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 19203239 ↗
• MalfunctionApr 3, 2024Use of Device Problem; Use of Device Problem

  ON 12/13/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE TIGHTROPE FROM AN AR-8958TDS DUAL TIGHTROPE SYNDESMOSIS IMPLANT SYSTEM, WOULD NOT TENSION ON ONE SIDE. THIS WAS DISCOVERED WHILE ASSEMBLING THE TIGHTROPE DURING A PROCEDURE ON (B)(6) 2022. CASE WAS COMPLETED BY USING AN INDIVIDUAL AR-8926T KNOTLESS TIGHTROPE.

  Patient problems: Insufficient Information

  MAUDE report 19033503 ↗