Arthrex® AR-8911DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867048805), received between Feb 4, 2020 and Sep 22, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  On 7th September 2026, it was reported by a Distributor via an Email that for 1 unit of AR-8911DS, Mini TightRope® Repair Kit, Cannulated, Stainless Steel, its suture was broken during final tensioning step. The surgeon checked the tunnel; there were no sharp fragment or hardware obstruction.This was detected during a Lisfranc procedure on (b)(6) 2026. The procedure was completed successfully by using additional TightRope. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852749 ↗
• MalfunctionMar 25, 2026Break

  ON 05TH MAR 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AR-8911DS MINI TIGHTROPE REPAIR BATCH 34065 SNAPPED WHEN DEPLOYING. THIS WAS DETECTED ON THE SAME DAY DURING PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 24686660 ↗
• MalfunctionJan 12, 2026Break

  ON 27TH DECEMBER 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-8911DS, MINI TIGHTROPE® REPAIR KIT, CANNULATED, STAINLESS STEEL, THE SUTURE BROKE WHEN THE SURGEON APPLIED TENSION. THIS WAS DETECTED DURING A LISFRANC PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER AR-8911DS TIGHTROPE IMPLANT WAS USED. THERE WAS NO REP PRESENT DURING THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 24039807 ↗
• MalfunctionDec 24, 2025Break; Break

  ON 12/04/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT FOR AN AR-8911DS MINI TIGHTROPE REPAIR KIT, DURING BUTTON REDUCTION, THE SUTURE BROKE. IT WAS REPORTED THAT BASED ON WHAT WAS OBSERVED, EXCESSIVE FORCE WAS APPLIED WHEN USING TWO FORCEPS. THIS WAS DISCOVERED DURING A LISFRANC FRACTURE FIXED WITH TWO TIGHTROPES PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED WITH ANOTHER TIGHTROPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887564 ↗
• MalfunctionOct 27, 2025Use of Device Problem; Use of Device Problem

  ON 09/30/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8911DS MINI TIGHTROPE REPAIR DID NOT DEPLOY PROPERLY. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389474 ↗
• MalfunctionJan 21, 2025Break; Break

  ON 27TH DECEMBER 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-8911DS, MINI TIGHTROPE REPAIR BROKE. THIS WAS DETECTED DURING A MIDFOOT FUSION PROCEDURE ON (B)(6) 2024. MINI TIGHTROPE BROKE WHEN TENSIONING. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM BY USING ANOTHER MINI TIGHT-ROPE INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21198400 ↗
• MalfunctionJun 11, 2024Break; Break

  ON 4/19/2023 IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT THE SUTURES FROM AN AR-8911DS MINI TIGHTROPE REPAIR KIT BROKE DURING REDUCTION. THIS WAS DISCOVERED DURING A LISFRANC PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED BY REMOVING EVERYTHING FROM INSIDE THE PATIENT AND USING A NEW AR-8911DS MINI TIGHTROPE KIT.

  Patient problems: Insufficient Information

  MAUDE report 19510883 ↗
• MalfunctionJun 7, 2024Break; Break

  ON 7/26/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8911DS MINI TIGHTROPE SUTURES BROKE DURING THE FINAL TENSIONING. SURGEON REMOVED EVERYTHING FROM INSIDE THE PATIENT AND USED AN AR-8913DS MINI TIGHTROPE WITH INSERTER TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A BUNION CORRECTION PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 19486223 ↗
• MalfunctionDec 21, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LISFRANC SURGERY DURING THE STRETCHING OF THE TIGHTROPE, THE SUTURES WERE TORN AND THE TIGHTROPE OPENED. THE STRETCHING WAS DONE IN A CONTROLLED AND CORRECT WAY. THE LITTLE BUTTON FELL INTO THE JOINT AND WAS RETRIEVED FROM THE PATIENT, WHICH CAUSED A PROCEDURAL DELAY. 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 18373873 ↗
• InjuryFeb 4, 2020Break

  IT WAS REPORTED BY A PATIENT'S RELATIVE THAT THE PATIENT HAD UNDERGONE A HALLUX VARUS PROCEDURE USING AN ARTHREX TIGHTROPE SEVERAL MONTHS PRIOR. THE PATIENT'S RELATIVE INDICATED THAT THE TIGHTROPE CONSTRUCT IS BELIEVED TO BE BROKEN. PATIENT IS SCHEDULED FOR A SECOND SURGERY ON (B)(6) 2019. PATIENT'S RELATIVE DID NOT HAVE FURTHER DETAILS BUT PROVIDED CONTACT INFORMATION FOR THE PATIENT. ADDITIONAL INFORMATION OBTAINED 10/15/2019: PATIENT CONFIRMED REVISION SURGERY TOOK PLACE ON (B)(6) 2019. PATIENT IS WORKING ON OBTAINING AND PROVIDING MEDICAL RECORDS. PART NUMBER IS STILL PENDING FROM THE EXPECTED MEDICAL RECORDS. PATIENT EXPECTS TO HAVE ALL MEDICAL RECORDS BY THE END OF (B)(6) 2019 AFTER THE FINAL POST-OP APPOINTMENT. THE MEDICAL RECORDS INDICATE THAT THE TIGHTROPE CONSTRUCT INITIALLY CORRECTED A HALLUX VARUS DEFORMITY WHICH WAS CAUSED BY THE PATIENT'S TWO PRIOR BUNION SURGERIES. THERE IS NO EVIDENCE THAT THE BUNION RETURNED. ACCORDING TO THE RECORDS THE TIGHTROPE LOST CORRECTION WHICH LED TO THE GREAT TOE MOVING BACK TO THE PRIOR VARUS POSITION. ADDITIONAL INFORMATION OBTAINED 1/9/2020: PATIENT PROVIDED MEDICAL RECORDS WHICH CONTAIN THE ARTHREX DEVICE PART NUMBER FROM THE PATIENT

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9667429 ↗