Arthrex® AR-8959TDSRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867352278), received between Apr 27, 2021 and Apr 30, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Positioning Failure

  IT WAS REPORTED THAT DURING A SURGERY TIGHTROPE HASN'T FLIPPED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044267 ↗
• MalfunctionFeb 19, 2026Break

  ON 02-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT DURING A SYNDESMOSIS REPAIR PROCEDURE ON (B)(6) 2026, BOTH AN AR-8959TDS SYNDESMOSIS TIGHTROPE XP BUTTRESS PLATE IMPLANT SYSTEM AND AN AR-8925SS SYNDESMOSIS TIGHTROPE XP WERE INSERTED THROUGH THE PLATE WITH THE BUTTONS FLIPPED AS INTENDED. WHEN THE INCLUDED TENSIONING HANDLES WERE USED, THE SUTURES BROKE BEFORE ADEQUATE REDUCTION COULD BE ACHIEVED. THE SAME ISSUE OCCURRED WITH BOTH INITIAL IMPLANTS. THE SURGEON THEN OPENED TWO ADDITIONAL SINGLE-IMPLANT KITS, AND THE SUTURE BREAKAGE RECURRED WITH ONE OF THOSE IMPLANTS AS WELL. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 05-FEB-2026: ON OPENING THE AR-8959TDS SYNDESMOSIS TIGHTROPE XP BUTTRESS PLATE IMPLANT SYSTEM (LOT 15119012), THE TWO INCLUDED TIGHTROPE IMPLANTS EXPERIENCED SUTURE BREAKAGE DURING TENSIONING. THE FACILITY THEN OPENED TWO AR-8925SS SYNDESMOSIS TIGHTROPE XP IMPLANTS, AND ONE OF THESE (LOT 15292557) EXHIBITED THE SAME SUTURE-FRACTURE ISSUE. THE SURGEON REPORTED THAT THE LATERAL ROUND BUTTON WAS GUIDED TO THE PLATE, AND APPROXIMATELY TWO TO THREE TENSIONING CYCLES WERE PERFORMED BEFORE THE SUTURES FRACTURED. TENSIONING WAS APPLIED AL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387234 ↗
• MalfunctionMay 13, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 6/10/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT THE TIGHTROPES FROM AN AR-8959TDS TIGHTROPE XP BUTTRESS PLATE IMPLANT SYSTEM RIPPED AND THE IMPLANTS FAILED. SURGEON WAS ABLE TO REMOVED ALL FRAGMENTS AND OPENED INDIVIDUAL TIGHTROPES TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 19297797 ↗
• MalfunctionMar 7, 2022Break

  ON 2/14/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A DRILL BIT FROM ANAR-8929TDS SYNDESMOSIS TIGHTROPE KIT BROKE OFF AND REMAINS IN PATIENT. THIS WAS DISCOVERED DURING A SYNDESMOSIS TIGHTROPE PROCEDURE ON (B)(6) 2022. SURGEON DID NOT WANT TO REMOVE THE BROKEN PIECE BECAUSE AFTER SURGERY, PATIENT WILL NOT BE ABLE TO WALK FOR 8 WEEKS AND WILL REASSESS IF NEED BE AFTER PATIENT STARTS WALKING AGAIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 13684340 ↗
• MalfunctionNov 30, 2021Break

  IT WAS REPORTED THAT DURING A SYNDESMOSIS REPAIR SURGERY WITH INTERNAL BRACE THE DEVICE DID NOT WORK PROPERLY. AFTER TIGHTENING THE SUTURES THE OTHER SUTURE WAS CUT AND THE SURGEON COULD NOT TIGHTEN IT. THE DEVICE BROKE INSIDE THE PATIENT AND ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. HE NEEDED TO CHANGE THE DEVICE TO A SINGLE PACKED TIGHTROPE IMPLANT TO CONTINUE WITH THE PROCEDURE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-8926T). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12896568 ↗
• MalfunctionApr 27, 2021Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SURGEON USED A AR-8959TDS BB TAK AND PLACED IN THE CENTRAL HOLE OF THE BUTTRESS PLATE TO KEEP THE PLATE STEADY. AFTER USING FLUOROSCOPY, THE SURGEON WANTED TO RELOCATE THE POSITION OF THE PLATE AND WENT TO REMOVE THE BB TAK. AS THE BB TAK WAS BEING REMOVED, THE DISTAL PORTION BROKE OFF AND BECAME EMBEDDED IN THE PATIENT. THE SURGEON WAS ABLE TO USE THE CANNULATED DRILL BIT FROM THE SET TO POP THE CORTEX AND REMOVE A SMALL FRAGMENT OF THE BB TAK; HOWEVER, A SMALL PIECE REMAINED IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11730902 ↗