Arthrex® AR-8925TRecalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00888867281608), received between May 17, 2018 and Sep 22, 2026 — classified as 13 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Break” (33 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 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  On 8 Sep 2026, it was reported by an Arthrex employee via email that an AR-8925T K-LESS T-ROPE W/DRV, SYN REPR, 's button and suture broke despite using the device according to its instructions. This occurred during a procedure. The procedure was completed successfully by using another AR-8925T. There was no patient harm, and all of the product/fragment was removed, and nothing remains in the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853742 ↗
• InjurySep 18, 2026Positioning Failure

  Patient problems: Failure of Implant

  MAUDE report 50828460 ↗
• MalfunctionAug 5, 2026Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50143499 ↗
• MalfunctionMar 26, 2026Device Dislodged or Dislocated

  ON 09 MAR 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AR-8925T K-LESS T-ROPE W/DRV, SYN REPR, TI BATCH 15502038 WAS PULLED OUT IN ITS WHOLE CONSTRUCT WHEN TUGGING IN THE LATERAL DIRECTION TO FLUSH THE OBLONG MEDIAL BUTTON TO BONE. POSSIBLY DUE TO CATCHING SOFT TISSUES ON THE MEDIAL SIDE BY THE OBLONG BUTTON, CAUSING IMPROPER SITTING OF OBLONG BUTTON. THIS WAS DETECTED DURING ANKLE FRACTURE & SYNDESMOSIS TIGHTROPE PROCEDURE ON (B)(6) 2026. NO FRAGMENTS RETAINED IN THE PATIENT¿S BODY AND PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 24705689 ↗
• MalfunctionMar 24, 2026Material Frayed

  ON 26-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-8925T SYNDESMOSIS TIGHTROPE FAILED DURING A PROCEDURE. THIS OCCURRED DURING AN ANKLE FRACTURE ON (B)(6) 2026; THE MEDIAL BUTTON SUTURES APPEAR TO BE FRAYED. THIS WAS DISCOVERED UPON CLOSING THE PATIENT. THE SURGEON DECIDED TO REMOVE THE DEVICE. THIS DELAYED THE CASE APPROXIMATELY 10 MINUTES, AND IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE CASE WAS COMPLETED USING ANOTHER AR-8925T SYNDESMOSIS TIGHTROPE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24680641 ↗
• MalfunctionMar 10, 2026Positioning Failure

  ON 17-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-8925T SYNDESMOSIS TIGHTROPE XP IMPLANTS EXPERIENCED AN ISSUE DURING USE. AFTER THE SURGEON FULLY TENSIONED THE CONSTRUCT AND CUT THE SUTURE TAILS, THE TENSION WAS LOST, AND VISIBLE ANTERIOR-POSTERIOR TRANSLATION OF THE FIBULAR BUTTON WAS OBSERVED. THE ISSUE OCCURRED DURING A PROCEDURE ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 25-FEB-2026: THIS OCCURRED DURING AN ANKLE FRACTURE PROCEDURE WITH A SYNDESMOTIC REPAIR. BOTH IMPLANTS WERE REMOVED AND REPLACED WITH ANOTHER AR-8925T SYNDESMOSIS TIGHTROPE XP IMPLANT FROM A DIFFERENT LOT. THERE WAS NO CASE DELAY, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558645 ↗
• MalfunctionMar 10, 2026Positioning Failure

  ON 17-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-8925T SYNDESMOSIS TIGHTROPE XP IMPLANTS EXPERIENCED AN ISSUE DURING USE. AFTER THE SURGEON FULLY TENSIONED THE CONSTRUCT AND CUT THE SUTURE TAILS, THE TENSION WAS LOST, AND VISIBLE ANTERIOR-POSTERIOR TRANSLATION OF THE FIBULAR BUTTON WAS OBSERVED. THE ISSUE OCCURRED DURING A PROCEDURE ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 25-FEB-2026: THIS OCCURRED DURING AN ANKLE FRACTURE PROCEDURE WITH A SYNDESMOTIC REPAIR. BOTH IMPLANTS WERE REMOVED AND REPLACED WITH ANOTHER AR-8925T SYNDESMOSIS TIGHTROPE XP IMPLANT FROM A DIFFERENT LOT. THERE WAS NO CASE DELAY, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558555 ↗
• MalfunctionMar 6, 2026Positioning Failure

  ON 13-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8925T SYNDESMOSIS TIGHTROPE XP, TITANIUM EXPERIENCED AN ISSUE DURING USE. DURING A RIGHT ANKLE FRACTURE PROCEDURE PERFORMED ON (B)(6) 2026, A 1/3 TUBULAR PLATE HAD BEEN FIXATED TO THE BONE. A 3.7 MM DRILL WAS USED TO CREATE A HOLE ACROSS THE DISTAL TIBIA AND FIBULA, AND THE AR-8925T DEVICE WAS INSERTED FROM LATERAL TO MEDIAL AND DEPLOYED. UPON TENSIONING, THE LATERAL BUTTON FAILED TO REDUCE TO THE BONE DUE TO WHAT APPEARED TO BE A KNOT LOCATED MEDIAL TO THE LATERAL BUTTON. ATTEMPTS TO LOOSEN THE KNOT WERE UNSUCCESSFUL, PREVENTING PROPER TENSIONING OF THE DEVICE. THE KNOTTED TIGHTROPE XP WAS CUT AND REMOVED FROM THE PATIENT. THE CASE WAS THEN COMPLETED USING A REPLACEMENT AR-8925T SYNDESMOSIS TIGHTROPE XP, TITANIUM, WITHOUT FURTHER ISSUES. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 19-FEB-2026: THE KNOT WAS IMMEDIATELY IDENTIFIED. WHEN TENSION WAS APPLIED, THE KNOT BEGAN TO FURTHER BALL UP BETWEEN THE BUTTON AND THE BONE. THE MEDIAL SIDE OF THE ANKLE WAS ALREADY SURGICALLY OPEN, ALLOWING THE SURGEON TO DIRECTLY VISUALIZE THE ISSUE WITHOUT THE USE OF FLUOROSCOPY. THE IMPLANT WAS REMOVED, AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531641 ↗
• MalfunctionFeb 18, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A LIGAMENT REPAIR SURGERY, WHEN USING THE DEVICE, IT BECAME ¿JAMMED¿ AND WAS DIFFICULT TO OPERATE. THE BUTTON AT THE FRONT MUST HAVE COME LOOSE IN THE CHANNEL BEFORE IT WAS INSERTED. NEVERTHELESS, ALL THE SUTURES WERE STILL ATTACHED TO THE APPLICATOR. THIS CAUSED THE BUTTON ITSELF TO BECOME ¿JAMMED¿ IN THE CHANNEL. 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 24376553 ↗
• MalfunctionJan 12, 2026Break

  ON 26TH DECEMBER 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-8925T, SYNDESMOSIS TIGHTROPE® XP, TITANIUM, THE NURSE STATED THAT THE IMPLANT WAS FAULTY AND THE TIGHTROPE SUTURE BROKE WHEN IT WAS BEING USED. THIS WAS DETECTED DURING AN ANKLE ORIF PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A NEW IMPLANT WAS OPENED.

  Patient problems: Insufficient Information

  MAUDE report 24039506 ↗
• MalfunctionOct 27, 2025Break; Break

  ON 25TH OCT 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-8925T, SYNDESMOSIS TIGHTROPE® XP, TITANIUM, THE SUTURE SNAPPED WHEN TENSIONING USING TENSIONING HANDLES. THIS WAS DETECTED DURING AN UNSPECIFIC PROCEDURE ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 23392620 ↗
• MalfunctionSep 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC FOOT SURGERY THE SUTURE TORE AFTER THE DEVICE WAS ALREADY INSERTED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH 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 23088887 ↗
• MalfunctionAug 22, 2025Break; Break

  ON 08/05/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-8925T SYNDESMOSIS TIGHTROPE XP SNAPPED WHEN THE SURGEON WENT TO TIGHTEN THE SUTURES DOWN ONTO THE BUTTON; THE INITIAL SUTURE SNAPPED. FURTHER ATTEMPTS TO SECURE IT CAUSED ADDITIONAL SUTURES TO BREAK, LEAVING NO REMAINING SUTURES FOR FIXATION. THE BUTTON AND BROKEN SUTURES WERE REMOVED FROM THE PATIENT, AND THE CASE WAS COMPLETED WITH A REPLACEMENT AR-8925T SYNDESMOSIS TIGHTROPE XP. NO SIGNIFICANT DELAY OR ADDED ANESTHESIA WAS ADMINISTERED, AND NO ADVERSE EFFECTS WERE REPORTED. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873628 ↗
• MalfunctionJun 6, 2025Break; Break

  ON 5/16/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8925T SYNDESMOSIS TIGHTROPE XP SUTURE BROKE, CAUSING LOSS OF FIXATION WITH THE BUTTON. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 6/5/2025.

  Patient problems: Insufficient Information

  MAUDE report 22159427 ↗
• MalfunctionMay 19, 2025Break; Break

  ON 04/30/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-8925T SYNDESMOSIS TIGHTROPES TIGHTENING SUTURE HAD SNAPPED. THIS OCCURRED DURING AN ANKLE FRACTURE ON 04/30/2025 WHILE BEING INSERTED INTO THE PATIENT, AND ALL FRAGMENTS WERE RETRIEVED. THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE PROCEEDED USING ANOTHER AR-8925T.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044920 ↗
• MalfunctionMay 6, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A SYNDESMOSIS RUPTUR SURGERY THE MEDIAL BUTTON FLIPPED TOO EARLY AT THE SPACE IN BETWEEN. 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 21972927 ↗
• MalfunctionApr 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 4/11/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-8925T SYNDESMOSIS TIGHTROPE XP, TITANIUM, HAD AN ISSUE DURING A SYNDESMOSIS REPAIR PROCEDURE ON (B)(6) 2025. WHEN THE SURGEON USED THE DEVICE, THE SUTURES RIPPED INSIDE THE PATIENT, NOT ALLOWING HIM TO CINCH THE DEVICE ADEQUATELY. THE SUTURES AND TWO BUTTONS WERE REMOVED FROM THE PATIENT. NOTHING ELSE BROKE INSIDE THE PATIENT, ONLY THE SUTURES, AND THERE WAS NO HARM. ANOTHER AR-8925T SYNDESMOSIS TIGHTROPE XP, TITANIUM, WITH A DIFFERENT UNKNOWN LOT NUMBER, WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE COMPLAINT DEVICE WAS DISCARDED, AND NO PICTURES WERE TAKEN. THE WAS A SLIGHT CASE DELAY OF 10 MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21910534 ↗
• MalfunctionApr 3, 2025Use of Device Problem; Difficult to Advance; Use of Device Problem; Difficult to Advance

  ON 03/14/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8925T SYNDESMOSIS TIGHTROPE XP HAD THE TIGHTROPE LOOSE AND HAD TO BE REPLACED. THIS ISSUE OCCURRED AFTER TENSIONING THE TIGHTROPE AND CUTTING OFF SUTURES, LEAVING A SUTURE TAIL. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 03/20/2025:THE CASE WAS COMPLETED USING ANOTHER AR-8925T SYNDESMOSIS TIGHTROPE XP. IT TOOK AN ADDITIONAL TEN MINUTES TO REMOVE THE IMPLANT AND INSERT ANOTHER IMPLANT. THE BUTTON AND SUTURES WERE FULLY REMOVED. NO ADVERSE EFFECTS HAVE BEEN REPORTED. THIS WAS DISCOVERED DURING AN ANKLE ORIF WITH SYNDESMOSIS REPAIR ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21764667 ↗
• MalfunctionFeb 19, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 2/3/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8925T SYNDESMOSIS TIGHTROPE XP BUTTON WOULD NOT DEPLOY FROM THE DRIVER. EVERYTHING WAS REMOVED, AND THE CASE WAS COMPLETED USING ANOTHER ANCHOR. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 21409668 ↗
• MalfunctionFeb 7, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A FOOT SURGERY THE ANCHOR DID NOT RELEASE. 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. UPDATE 28-JAN-2025: FURTHER INFORMATION WAS PROVIDED THAT THE BUTTON DID NOT FLIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21334185 ↗
• MalfunctionOct 4, 2024Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  ADDITIONAL INFORMATION RECEIVED ON 10/7/2024: THIS WAS DISCOVERED DURING AN ANKLE ORIF PROCEDURE. THE SUTURE SHREDDED IN THE PATIENT DURING INSERTION, AND ALL FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED USING AN AR-8925SS SYNDESMOSIS TIGHTROPE XP. THE CASE WAS DELAYED FIVE MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20370197 ↗
• InjurySep 20, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-8925T SYNDESMOSIS TIGHTROPE XP SUTURE BROKE DURING TENSIONING. A SKIN INCISION WAS MADE ON THE MEDIAL SIDE OF THE TIBIA TO REMOVE THE ENTIRE IMPLANT. THE CASE WAS COMPLETED USING ANOTHER AR-8925T SYNDESMOSIS TIGHTROPE XP. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024 TO REPAIR A TIBIOFIBULAR LIGAMENT INJURY ACCOMPANIED BY A FIBULA FRACTURE. IT WAS ALSO REPORTED THAT THE PATIENT HAD AN INFECTION UNRELATED TO THE ARTHREX IMPLANT OR PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 20265701 ↗
• MalfunctionSep 18, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE SURGERY THE TIGHT ROPE SYSTEM WAS REJECTED BECAUSE THE FLIPPING EFFECT COULD NOT BE RELEASED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 20250637 ↗
• MalfunctionSep 12, 2024Break; Break

  SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-8925T SYNDESMOSIS TIGHTROPES SUTURE BROKE. THIS OCCURRED DURING A SYNDESMOSIS REPAIR ON (B)(6) 2024. WHEN TENSIONING THE SUTURES, THEY RIPPED, RESULTING IN THE BUTTON BEING INOPERABLE. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE CASE CONTINUED USING A THIRD AR-8925T. THERE WAS NO PATIENT HARM. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199004 ↗
• MalfunctionSep 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-8925T SYNDESMOSIS TIGHTROPE XP BUTTON WAS NOT ATTACHED TO THE INSERTER. THE SURGEON COULD NOT REATTACH THE BUTTON ON THE INSERTER, AS THIS WAS NOTICED DURING INSERTION INTO THE BONE TUNNEL. THE BUTTON WAS ATTACHED BY THE SUTURES AND NEVER LOOSE IN THE PATIENT. THE CASE WAS COMPLETED USING ANOTHER R-8925T SYNDESMOSIS TIGHTROPE XP. THIS WAS DISCOVERED DURING A SYNDESMOSIS REPAIR PROCEDURE ON (B)(6) 2024. THE CASE WAS NOT DELAYED.

  Patient problems: Insufficient Information

  MAUDE report 20193372 ↗