Arthrex® AR-8926SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00888867049079), received between Nov 7, 2016 and Jan 15, 2026 — classified as 6 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Break

  ON 31-DEC-2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT (QTY. 2) OF AN AR-8926SS KNOTLESS T-ROPE EXPERIENCED A MALFUNCTION. WHEN THE DOCTOR PULLED THE SUTURES ONE BY ONE TO CLOSE THE SYNDESMOSIS, THE TIGHTROPE SUTURES BROKE; ANOTHER TIGHTROPE WAS PROVIDED TO PERFORM THE REPAIR, AND WHEN THE SUTURES WERE PULLED AGAIN, THEY BROKE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079282 ↗
• MalfunctionJan 15, 2026Break

  ON 31-DEC-2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT (QTY. 2) OF AN AR-8926SS KNOTLESS T-ROPE EXPERIENCED A MALFUNCTION. WHEN THE DOCTOR PULLED THE SUTURES ONE BY ONE TO CLOSE THE SYNDESMOSIS, THE TIGHTROPE SUTURES BROKE; ANOTHER TIGHTROPE WAS PROVIDED TO PERFORM THE REPAIR, AND WHEN THE SUTURES WERE PULLED AGAIN, THEY BROKE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079065 ↗
• MalfunctionJan 5, 2026Use of Device Problem

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-8926SS KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANTS WERE LOADED INCORRECTLY, RESULTING IN UNSUCCESSFUL DEPLOYMENT. A THIRD AR-8926SS KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANTS FROM A DIFFERENT LOT NUMBER WAS OPENED AND FUNCTIONED AS INTENDED, ALLOWING THE PROCEDURE TO CONTINUE. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 19-DEC-2025: DURING AN ANKLE ORIF WITH SYNDESMOTIC REPAIR, THE BUTTONS AND SUTURES WERE REMOVED ENTIRELY FROM THE PATIENT. THE PROCEDURE WAS DELAYED BY APPROXIMATELY FIVE MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 23960321 ↗
• MalfunctionJan 5, 2026Use of Device Problem

  ON 16-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-8926SS KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANTS WERE LOADED INCORRECTLY, RESULTING IN UNSUCCESSFUL DEPLOYMENT. A THIRD AR-8926SS KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANTS FROM A DIFFERENT LOT NUMBER WAS OPENED AND FUNCTIONED AS INTENDED, ALLOWING THE PROCEDURE TO CONTINUE. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 19-DEC-2025: DURING AN ANKLE ORIF WITH SYNDESMOTIC REPAIR, THE BUTTONS AND SUTURES WERE REMOVED ENTIRELY FROM THE PATIENT. THE PROCEDURE WAS DELAYED BY APPROXIMATELY FIVE MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 23960203 ↗
• MalfunctionJul 17, 2025Break; Break

  ON 23RD JUNE 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR 3 UNITS OF AR-8925SS, SYNDESMOSIS TIGHTROPE® XP, STAINLESS STEEL, THE TIGHTROPES SNAPPED. THIS WAS DETECTED DURING USE IN AN UNSPECIFIED PROCEDURE ON (B)(6) 2025. 25TH JUNE 2025: THE COMPLAINT INITIATOR PROVIDED HIS REPLY AND THE UPDATED EVENT DESCRIPTION IS AS FOLLOWS: ON 23RD JUNE 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR 2 UNITS OF AR-8925SS, SYNDESMOSIS TIGHTROPE® XP, STAINLESS STEEL, AND 1 UNIT OF AR-8926SS, KNOTLESS TIGHTROPE® SYNDESMOSIS REPAIR IMPLANT, STAINLESS STEEL, THE TIGHTROPES SNAPPED. THIS WAS DETECTED DURING USE IN AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A SCREW WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531005 ↗
• MalfunctionMar 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WEAS REPORTED THAT DURING A SYNDESMOSIS REPAIR SURGERY THE TIGHTROPE TORE DURING THE FINAL STRETCHING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-8952T). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21653210 ↗
• MalfunctionMar 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WEAS REPORTED THAT DURING A SYNDESMOSIS REPAIR SURGERY THE TIGHTROPE TORE DURING THE FINAL STRETCHING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-8952T). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652945 ↗
• MalfunctionOct 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A SYNDESMOSIS REPAIR SURGERY THE SUTURE BROKE JUST AT THE BUTTON. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568586 ↗
• MalfunctionOct 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A SYNDESMOSIS REPAIR SURGERY THE SUTURE BROKE JUST AT THE BUTTON. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568554 ↗
• MalfunctionJun 14, 2024Break; Break

  ON 12/7/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT (2) AR-8926SS KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR SUTURE BROKE OFF DURING THE FINAL TIGHTENING STEP. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2022. CASE WAS COMPLETED BY USING A NEW TIGHTROPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19539293 ↗
• MalfunctionJun 13, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THE DURING AN ANKLE CASE, THE SUTURES PULLED THROUGH THE BUTTON. THE SUTURES AND THE BUTTON WERE REMOVED FROM THE PATIENT AND ANOTHER AR-8926SS WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528205 ↗
• MalfunctionJun 3, 2024Break; Break

  ON 1/10/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-8926SS KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANT SUTURES BREAK AND THE BUTTON IS LOOSEN. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. ADDITIONAL INFORMATION RECEIVED 1/11/2022: THIS WAS DISCOVERED DURING AN ANKLE FRACTURE REDUCTION PROCEDURE AND SURGEON WAS ABLE TO COMPLETED USING ANOTHER AR-8926SS TIGHTROPE FROM LOT NUMBER 29496. AFTER THE SUTURES GOT CUT AND BUTTON WAS LOOSE, SURGEON REMOVED EVERYTHING FROM INSIDE THE PATIENT AND NOTHING WAS LEFT BEHIND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446621 ↗
• MalfunctionMay 21, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 4/19/2022 IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-8926SS KNOTLESS TIGHTROPES SUTURE WAS CUT DURING SURGERY. THIS OCCURRED DURING A PROCEDURE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19361229 ↗
• MalfunctionMay 20, 2024Break; Break

  ON 12/7/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT (2) AR-8926SS KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR SUTURE BROKE OFF DURING THE FINAL TIGHTENING STEP. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2022. CASE WAS COMPLETED BY USING A NEW TIGHTROPE.

  Patient problems: Insufficient Information

  MAUDE report 19352267 ↗
• MalfunctionMay 7, 2024Component Misassembled; Component Misassembled

  ON 04/14/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A AR-8926SS TIGHTROPES PASSING SUTURE ON THE MEDIAL SIDE APPEARS TO BE IN THE INCORRECT HOLE OF THE BUTTON. THIS WAS DISCOVERED ON (B)(6) 2022 DURING AN ANKLE FRACTURE WHEN THE SUTURE APPEARED TO BE IN THE INCORRECT HOLE OF THE BUTTON AND THE DEVICE WAS THEN DECLARED UNUSABLE. A TIGHTROPE XP WAS USED TO COMPLETE THE CASE AND THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19258301 ↗
• MalfunctionFeb 29, 2024Break; Break

  ON 2/12/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-8926SS KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANT BROKE DIRECTLY FROM THE BUTTON WITHOUT FRICTION IN THE BONE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 02/21/2024: THE DATE OF THE PROCEDURE WAS (B)(6) 2024. THE PROCEDURE PERFORMED WAS AN ANKLE RAFI WITH DEX SYSTEM, PLUS SISNDEMOSYS REDUCTION. EACH BUTTON BROKE WHEN STARTING THE ONE-BY-ONE REDUCTION OF THE SUTURES. WHEN THE SUTURES BROKE, EACH BUTTON CAME OUT ON EACH SIDE OF THE ANKLE (MEDIAL AND LATERAL). THERE WAS A 40-MINUTE DELAY AND ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE CASE WAS COMPLETED BY REASSEMBLING THE SYSTEM WITH INDEPENDENT SUTURES (FIBERWIRE 5).

  Patient problems: Insufficient Information

  MAUDE report 18807593 ↗
• MalfunctionFeb 29, 2024Break; Break

  ON 2/12/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-8926SS KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANT BROKE DIRECTLY FROM THE BUTTON WITHOUT FRICTION IN THE BONE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 2/21/24: THE DATE OF THE PROCEDURE WAS (B)(6) 2024. THE PROCEDURE PERFORMED WAS AN ANKLE RAFI WITH DEX SYSTEM, PLUS SISNDEMOSYS REDUCTION. EACH BUTTON BROKE WHEN STARTING THE ONE-BY-ONE REDUCTION OF THE SUTURES. WHEN THE SUTURES BROKE, EACH BUTTON CAME OUT ON EACH SIDE OF THE ANKLE (MEDIAL AND LATERAL). THERE WAS A 40-MINUTE DELAY AND ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE CASE WAS COMPLETED BY REASSEMBLING THE SYSTEM WITH INDEPENDENT SUTURES (FIBERWIRE 5).

  Patient problems: Insufficient Information

  MAUDE report 18807503 ↗
• MalfunctionFeb 21, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 1/3/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-8926SS KNOTLESS TIGHTROPE SUTURE TORE DURING SURGERY. ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THERE WAS NO CASE DELAY OR ADDITIONAL ANESTHESIA ADMINISTERED. THE CASE WAS COMPLETED USING ANOTHER AR-8926SS FROM AN UNKNOWN LOT. THIS WAS DISCOVERED DURING AN ORIF PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18747782 ↗
• MalfunctionJan 15, 2024Break; Break

  IT WAS REPORTED THAT DURING A SYNDESMOSIS REPAIR SURGERY THE SUTURES BROKE 3 TIMES IN A ROW. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY AND THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.FURTHER INFORMATION REVEALED THAT THE SURGERY FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART ID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18510655 ↗
• MalfunctionJan 15, 2024Break; Break

  IT WAS REPORTED THAT DURING A SYNDESMOSIS REPAIR SURGERY THE SUTURES BROKE 3 TIMES IN A ROW. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY AND THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. FURTHER INFORMATION REVEALED THAT THE SURGERY FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART ID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18510654 ↗
• MalfunctionJan 15, 2024Break; Break

  IT WAS REPORTED THAT DURING A SYNDESMOSIS REPAIR SURGERY THE SUTURES BROKE 3 TIMES IN A ROW. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY AND THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. FURTHER INFORMATION REVEALED THAT THE SURGERY FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART ID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18510653 ↗
• MalfunctionJan 12, 2024Break; Break

  ON 12/2/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-8926SS KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR SUTURE BROKE OFF DURING THE FINAL TIGHTENING STEP. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2022. CASE WAS COMPLETED BY USING A NEW TIGHTROPE.

  Patient problems: Insufficient Information

  MAUDE report 18503332 ↗
• MalfunctionDec 29, 2023Break; Break

  ON 5/31/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT WHILE USING (2) AR-8926T KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANT SYSTEM, THE SUTURES BROKE CONSECUTIVELY WHILE CINCHING DOWN. EVERYTHING WAS REMOVED FROM THE PATIENT AND SURGEON OPENED AN AR-8926SS KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANT SYSTEM. AT THIS POINT, THE SAME THING HAPPENED, THE SUTURE BROKE WHILE TENSIONING AND CINCHING DOWN. SURGEON WAS ABLE TO COMPLETE THE CASE WITH ANOTHER AR-8926SS KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 18418697 ↗
• MalfunctionDec 21, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SYNDESMOSIS SURGERY THE KNOT ON THE ENBO-BUTTONS DOESN'T SLIDE WELL AT ALL. 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 18374402 ↗
• MalfunctionDec 21, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SYNDESMOSIS SURGERY THE KNOT ON THE ENBO-BUTTONS DOESN'T SLIDE WELL AT ALL. 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 18374232 ↗