Arthrex® AR-8926TRecalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00888867049086), received between Aug 2, 2016 and Sep 30, 2026 — classified as 5 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Break” (27 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  On 11th September 2026, it was reported by a distributor via an email that for 1 unit of AR-8926T, Knotless TightRope® Syndesmosis Repair Implant, Titanium, its suture broke during loop shortening step. The tunnel was checked and there was no sharp fragment or screw penetrated. This was detected during an Ankle ORIF on (b)(6) 2026. The procedure was completed successfully by using additional AR-8926T in the same tunnel and completed the fixation. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949542 ↗
• MalfunctionAug 26, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50451629 ↗
• MalfunctionApr 10, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SYNDESMOTIC RUPTURE SURGERY THE SUTURES OF THE DEVICE TORE. PER COMPLAINT REPORTER 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 24839934 ↗
• MalfunctionJan 21, 2026Positioning Failure

  ON 6 JANUARY 2026, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-8926T TIGHTROPE (LOT 33696) WAS UNABLE TO SELF-LOCK AT THE END OF THE PROCEDURE WHEN THE EXCESS PULLING SUTURE WAS BEING CUT. THE ISSUE WAS DETECTED DURING A SYNDESMOSIS REPAIR. THE SURGEON AND DISTRIBUTOR REPRESENTATIVE CONFIRMED THAT THE SUTURE REMAINED INTACT THROUGHOUT BUTTON DEPLOYMENT, TENSIONING, AND TRIMMING; HOWEVER, THE TIGHTROPE FAILED TO LOCK AS EXPECTED. THE SURGEON SUBSEQUENTLY REMOVED THE AFFECTED TIGHTROPE BY CUTTING THE SUTURE AND PROCEEDED WITH AN ADDITIONAL TIGHTROPE, MANUALLY TYING A KNOT TO AVOID ANY POTENTIAL LOCKING DEFECT OCCURRING AGAIN IN THE SAME CASE. THE DEFECTIVE UNIT MAY HAVE NOT BEEN COMPLETE IN ITS ORIGINAL PACKAGING. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130004 ↗
• MalfunctionDec 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8926T KNOTLESS T-ROPE SYNDESMOSIS REPAIR HAD BEEN SHREDDED BEFORE FINAL TENSIONING. THEY HAD TO OPEN A NEW ONE AND CUT OUT THE FAULTY ONE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED ON 12/09/2025. ADDITIONAL INFORMATION WAS RECEIVED ON 10-DEC-2025: THIS ISSUE WAS DISCOVERED DURING A SYNDESMOSIS PROCEDURE, RESULTING IN AN APPROXIMATE FIVE-MINUTE DELAY WHILE A NEW PRODUCT WAS OPENED. ALL DETACHED FRAGMENTS WERE ACCOUNTED FOR AND RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887784 ↗
• MalfunctionDec 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE SURGERY TO TREAT CHRONIC SYNDESMOTIC INSTABILITY THE SUTURE OF THE TIGHTROPE TORE WHEN TIGHTENED. THE TORN PIECES WERE REMOVED FROM THE PATIENT. PER COMPLAINT REPORTER 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 23758104 ↗
• MalfunctionOct 24, 2025Break; Break

  ADDITIONAL INFORMATION: THE CASE WAS COMPLETED USING ANOTHER AR-8926T KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANT. THE EVENT OCCURRED DURING THE INSERTION PROCESS, PRIOR TO THE IMPLANT BEING FULLY PLACED OR TRACTION BEING APPLIED. THE SURGERY WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. ALL DETACHED FRAGMENTS, INCLUDING BUTTONS AND SUTURES, WERE ACCOUNTED FOR AND RETRIEVED DURING THE PROCEDURE. NO ADVERSE EFFECTS WERE REPORTED DURING OR FOLLOWING THE PROCEDURE AS A RESULT OF THIS ISSUE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377740 ↗
• MalfunctionAug 6, 2025Break; Break

  ON 07/18/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-8926T KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANT EXPERIENCED BREAKAGE WHEN PULLING THE SUTURES TO LOCK THE BUTTON. THE CASE WAS COMPLETED, AND NO FURTHER DETAILS WERE PROVIDED. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 07/29/2025: THE FAILED AR-8926T KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANT WAS SUCCESSFULLY REMOVED WITHOUT COMPLICATION, AND A NEW SWIVELOCK IMPLANT WAS PLACED TO COMPLETE THE PROCEDURE. THE LOCKING MECHANISM WAS PROPERLY ENGAGED BEFORE THE SUTURES WERE PULLED. THE PATIENT¿S BONE QUALITY WAS NOTED TO BE GOOD, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. THE SURGERY WAS COMPLETED WITHIN THE SCHEDULED 60-MINUTE TIMEFRAME, AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR SIGNIFICANT DAMAGE POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730628 ↗
• MalfunctionAug 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SYNDESMOSIS RUPTURE SURGERY THE TIGHTROPE TORE DURING INSERTION. ALL PARTS WERE RETRIEVED. PER COMPLAINT REPORTER 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 22699755 ↗
• MalfunctionJun 2, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-8926T KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANT SUTURES BROKE FROM THE TIBIAL PLATE. THIS WAS DISCOVERED DURING A SYNDESMOSIS PROCEDURE ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 22124765 ↗
• MalfunctionApr 18, 2025Break; Break

  ON 3RD APRIL 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-8926T, KNOTLESS TIGHTROPE® SYNDESMOSIS REPAIR IMPLANT, TITANIUM, THE PULLING SUTURE BROKE WHEN SURGEON TRIED TO PULL OUT FROM THE TUNNEL. THIS WAS DETECTED DURING AN ANKLE SCOPE PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER IMPLANT. UPDATE ON 3RD APRIL 2025: THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865166 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A SYNDESMOSIS RUPTURE SURGERY WHEN TIGHTENING THE SUTURE CONSTRUCT, THE SUTURE BROKE AT THE HEIGHT OF THE BUTTON. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER 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 21409928 ↗
• MalfunctionNov 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A REVISION OF AN ANKLE FRACTURE AND A SYNDESMOSIS SURGERY THE SURGEON NOTED DURING A FINAL CHECK THAT THE DEVICE HAD A YIELDED TENSION BY AROUND 2 MM. PER COMPLAINT REPORTER 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 20632407 ↗
• MalfunctionNov 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A REVISION OF AN ANKLE FRACTURE AND A SYNDESMOSIS SURGERY THE SURGEON NOTED DURING A FINAL CHECK THAT THE DEVICE HAD A YIELDED TENSION BY AROUND 2 MM. PER COMPLAINT REPORTER 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 20632208 ↗
• MalfunctionOct 15, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANKLE JOINT SURGERY THE TIGHTROPE TORE. PER COMPLAINT REPORTER 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 20454742 ↗
• MalfunctionSep 17, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A FOOT SYNDESMOSYS SURGERY THE TIGHTROPE BUTTON, WHERE THE FOUR THREADS GO THROUGH, THE TIGHTROPE BECOMES LOOSE AGAIN AFTER TIGHTENING. IT DOES NOT HOLD. 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 20238373 ↗
• MalfunctionJun 16, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SYNDESMOSES TIGHTROPE SURGERY THE TIGHTROPE TORE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 19544738 ↗
• MalfunctionJun 14, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DEVICE COULD NOT BE TENSIONED SUFFICIENTLY BECAUSE IT LOCKED UP PREMATURELY. IT HAD TO BE REMOVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. NO FURTHER INFORMATION WAS PROVIDED. UPDATE AVOE 06-APR-2021: THE ARTHROSCOPY 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 19539180 ↗
• MalfunctionJun 11, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ANKLE FRACTURE WITH SYNDESMOSIS STABILIZATION USING AN INTERNAL BRACE AND KNOTLESS TIGHTROPE, WHILE THE SURGEON WAS PULLING BY HAND ON THE SUTURE LIMBS TO TIGHTEN THE TIGHTROPE, THE SUTURE SNAPPED AT THE SECTION BEHIND THE BUTTON. THE SURGEON REMOVED THE TIGHTROPE AND FINISHED THE PROCEDURE WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS FURTHER REPORTED THAT AN ARTHREX TITANIUM ANKLE FRACTURE PLATE, AR-9943BR-06S WAS USED WITH THE TIGHTROPE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 29-OCT-2021 UPDATE (B)(6) FURTHER INFORMATION WERE PROVIDED THAT THE BUTTON WAS STILL ATTACHED ON THE MEDIAL SIDE WITH THE GUIDE WIRE AND STATURES STILL ATTACHED, AND EVERYTHING WAS EASILY RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509414 ↗
• MalfunctionJun 10, 2024Break; Break

  ON 4/10/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE TIGHTROPE FROM AN AR-8926T KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANT WAS NOT TIGHTENING DOWN APPROPRIATELY. THE SURGEON CONTINUED TO TRY TO PULL BACK ON THE SUTURE, AND IT EVENTUALLY JUST SNAPPED. THE SUTURES WERE CUT, AND ANOTHER AR-8926T KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANT WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE WITH SYNDESMOSIS REPAIR PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505539 ↗
• MalfunctionJun 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SINDESMOSIS INSTABILITY SURGERY AFTER POSITIONING THE KNOTLESS TIGHROPE AND PULLING THE FIBERWIRE SUTURES, THE SYSTEM BROKE / FRAYED THE FIBERWIRE. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. 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 19505252 ↗
• MalfunctionJun 10, 2024Break; Break

  ON 3/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A SUTURE FROM AN AR-8926T KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANT SYSTEM BROKE DURING TENSIONING. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED USING ANOTHER TIGHTROPE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19498265 ↗
• MalfunctionJun 7, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SYNDESMOSIS REPAIR SURGERY THE SUTURE OF THE IMPLANT TORE WHEN THE IMPLANT WAS PLACED, EVEN THOUGH THE SURGEON DID NOT PULL MUCH ON THE IMPLANT. 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 19484483 ↗
• MalfunctionJun 6, 2024Break; Break

  ON 3/14/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE TENSIONING SUTURE FROM AN AR-8926T KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANT SNAPPED WHEN TENSIONING THE BUTTON DOWN TO THE PLATE. ANOTHER AR-8926T KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANT WAS OPENED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19480319 ↗
• MalfunctionJun 3, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE TIGHTROPE DID NOT CLOSE WHILE IT WAS TIGHTENED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 19452858 ↗