Arthrex® AR-8925SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00888867281615), received between Jan 2, 2019 and Apr 22, 2026 — classified as 19 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Break” (42 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 79 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2026Patient Device Interaction Problem

  ON 02-JAN-2025, A PATIENT CALLED IN REPORTING THAT AFTER UNDERGOING AN ANKLE PROCEDURE IN (B)(6) 2025, SHE HAD EXPERIENCED A REACTION, ALONG WITH EXPERIENCING HER SKIN CHANGING, AND PAIN NEAR HER ANKLE. ADDITIONAL INFORMATION WAS PROVIDED ON 24-MAR-2026 WHERE THE PATIENT REPORTED THAT SHE UNDERWENT A LEFT ANKLE PROCEDURE FOR A DISPLACED BIMALLEOLAR FRACTURE OF THE LOWER LEG ON (B)(6) 2025 WHERE AN AR-8943DL-04 LOCKING DISTAL FIBULA PLATE, AR-8827-18 LOW PROFILE SCREW¿, 2.7 X 18 MM, (3) AR-8827CL-12 KREULOCK¿ COMPRESSION SCREW, SS, 2.7 MM X 12 MM, AR-8827CL-14 KREULOCK¿ COMPRESSION SCREW, SS, 2.7 MM X 14 MM, (2) AR-8827CL-16 KREULOCK¿ COMPRESSION SCREW, SS, 2.7 MM X 16 MM, (3) AR-8835CL-12 KREULOCK¿ COMPRESSION SCREW, SS, 3.5 MM X 12 MM, AR-8835-14 LOW PROFILE SCREW¿, SS, 3.5 X 14 MM, CORTICAL, AND AN AR-8925SS SYNDESMOSIS TIGHTROPE® XP, STAINLESS STEEL WERE IMPLANTED. THE PATIENT BEGAN TO EXPERIENCE THE FOLLOWING SYMPTOMS IN (B)(6) 2025; RUNNY NOSE, DIARRHEA, BLURRED VISION, SENSITIVITY TO THE ANKLE, BOTTOM OF THE TOES ACHE, CHANGES IN SKIN, BLOOD PRESSURE GOING UP AND DOWN, BACK OF HEELS ACHE, ITCHY ANKLE; THAT IS BEING TREATED WITH A CREAM, SHARP PAIN IN THE ANKLE, RIGHT EAR BLOC

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 24957163 ↗
• MalfunctionMar 30, 2026Break

  ON 09-MAR-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8925SS SYNDESMOSIS TIGHTROPE XP BROKE UPON INSERTION. THE SURGEON WAS PERFORMING FINAL TENSIONING WHEN ONE OF THE SUTURES SNAPPED WITHIN THE IMPLANT. THE CASE WAS COMPLETED BY LEAVING THE DAMAGED TIGHTROPE IN PLACE AND IMPLANTING AN ADDITIONAL TIGHTROPE ONE HOLE HIGHER. FLUOROSCOPIC IMAGING CONFIRMED NO FURTHER SYNDESMOTIC MOVEMENT. THIS ISSUE OCCURRED DURING A PROCEDURE ON (B)(6) 2026. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 11-MAR-2026: THIS OCCURRED DURING AN ISOLATED ANKLE SYNDESMOSIS REPAIR PROCEDURE. THE CASE WAS COMPLETED USING A REPLACEMENT AR-8925SS SYNDESMOSIS TIGHTROPE XP. THERE WAS NO CASE DELAY, NO ADDITIONAL ANESTHESIA TIME, AND THE BONE QUALITY WAS REPORTED AS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712932 ↗
• MalfunctionMar 18, 2026Break

  ON 25-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8925SS SYNDESMOSIS TIGHTROPE XP EXPERIENCED AN ISSUE DURING AN ANKLE FRACTURE REPAIR PROCEDURE PERFORMED ON (B)(6) 2026. WHILE TENSIONING THE TIGHTROPE XP, THE SUTURES BROKE BEFORE FINAL FIXATION COULD BE ACHIEVED, AND THE SUTURES APPEARED TO HAVE BROKEN AT THE LATERAL BUTTON. THE MEDIAL INCISION HAD ALREADY BEEN MADE FOR THE ASSOCIATED MEDIAL FRACTURE, WHICH ALLOWED THE SURGEON TO REMOVE BOTH THE MEDIAL AND LATERAL BUTTONS. A NEW TIGHTROPE IMPLANT WAS THEN OPENED AND USED TO COMPLETE THE FIXATION. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 02-MAR-2026: THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634535 ↗
• MalfunctionMar 16, 2026Break

  ON (B)(6), IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8925SS SYNDESMOSIS TIGHTROPE XP SUTURE BROKE PREMATURELY DURING TENSIONING. THE IMPLANT WAS REMOVED FROM THE PATIENT. THIS ISSUE WAS DISCOVERED DURING A SYNDESMOSIS REPAIR PROCEDURE ON (B)(6). ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6): TWO AR-8925SS SYNDESMOSIS TIGHTROPE XP DEVICES EXPERIENCED PREMATURE SUTURE BREAKAGE DURING TENSIONING. TWO ADDITIONAL AR-8925SS DEVICES WERE OPENED TO COMPLETE THE PROCEDURE, AND THE PROCEDURE CONTINUED WITHOUT FURTHER ISSUE. THE CASE WAS DELAYED BY APPROXIMATELY FIVE MINUTES TO REMOVE THE BROKEN TIGHTROPE AND PLACE A NEW ONE. NO ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 24607433 ↗
• MalfunctionMar 16, 2026Break

  ON (B)(6), IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8925SS SYNDESMOSIS TIGHTROPE XP SUTURE BROKE PREMATURELY DURING TENSIONING. THE IMPLANT WAS REMOVED FROM THE PATIENT. THIS ISSUE WAS DISCOVERED DURING A SYNDESMOSIS REPAIR PROCEDURE ON (B)(6). ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6): TWO AR-8925SS SYNDESMOSIS TIGHTROPE XP DEVICES EXPERIENCED PREMATURE SUTURE BREAKAGE DURING TENSIONING. TWO ADDITIONAL AR-8925SS DEVICES WERE OPENED TO COMPLETE THE PROCEDURE, AND THE PROCEDURE CONTINUED WITHOUT FURTHER ISSUE. THE CASE WAS DELAYED BY APPROXIMATELY FIVE MINUTES TO REMOVE THE BROKEN TIGHTROPE AND PLACE A NEW ONE. NO ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 24607294 ↗
• MalfunctionFeb 24, 2026Material Split, Cut or Torn

  ON 06-FEB-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT WHEN ADJUSTING AN AR-8925SS SYNDESMOSIS TIGHTROPE, PULLING ON THE SUTURES CUTS THEM. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24427779 ↗
• 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387324 ↗
• MalfunctionJan 22, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A SURGERY THE CANNULATED DRILL BIT FROM THE SET AR-8925SS (LOT: 15381169) DID NOT DRILL CONTINUOUSLY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24143948 ↗
• MalfunctionJul 17, 2025Break; Break

  ON (B)(6) 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. ON (B)(6) 2025 - THE COMPLAINT INITIATOR PROVIDED HIS REPLY AND THE UPDATED EVENT DESCRIPTION IS AS FOLLOWS: ON (B)(6) 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 22531004 ↗
• MalfunctionJul 17, 2025Break; Break

  ON (B)(6) 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. ON (B)(6) 2025 - THE COMPLAINT INITIATOR PROVIDED HIS REPLY AND THE UPDATED EVENT DESCRIPTION IS AS FOLLOWS: ON (B)(6) 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 22531002 ↗
• MalfunctionJul 9, 2025Material Fragmentation; Difficult to Advance; Material Fragmentation; Difficult to Advance

  ON 06/13/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8925SS SYNDESMOSIS TIGHTROPE XP EXHIBITED ISSUES WITH ITS SOLID DRILL BIT DURING USE. SPECIFICALLY, THE BIT DID NOT CUT THROUGH BONE EFFECTIVELY AND DEVELOPED BLACK MARKS AFTER USE. DEBRIS WAS PRODUCED DURING THE CASE, AND NO BREAKAGE WAS REPORTED. THE CASE WAS COMPLETED, AND NO ADDITIONAL DETAILS WERE PROVIDED. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 07/01/2025: THE DEBRIS WAS PRODUCED FROM "BURNING BONE" CAUSED BY THE DRILL BIT, AND THE BLACK MARKS CAME FROM BURNING BONE SINCE THERE WAS DIFFICULTY WITH THE DRILL CUTTING THROUGH BONE. THERE WAS RESISTANCE TO THE POINT WHERE THE BONE BEGAN SMOKING, AND THE DRILL AND BONE BECAME DISCOLORED, AND THEY COULD HEAR THE DRILL WORKING TO TRY AND CUT THROUGH THE BONE. THERE WAS NO DISCOLORATION PRESENT BEFORE THE DRILL WAS USED. THE PATIENT'S BONE QUALITY WAS POOR, AND THAT OF AN OLDER PATIENT. WHEN USING OTHER DRILLS THROUGHOUT THE PROCEDURE, THERE WAS NO DIFFICULTY. THE CASE WAS COMPLETED USING AR-8943-16 2.0 MM DRILL BIT AS A PILOT DRILL. THE CASE WAS DELAYED 5-10 MINUTES

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

  MAUDE report 22462701 ↗
• InjuryJul 8, 2025Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 07/08/2025: THE AR-8973DS FIBULOCK IMPLANT SYSTEM HAD THE END CAP IN THE KIT INSERTED INTO THE FIBULOCK NAIL DURING THE INITIAL PROCEDURE. DURING THE ROH/TTC REVISION, THE END CAP WAS REMOVED BEFORE THE EXTRACTION OF THE BROKEN FIBULAR NAIL. THE END CAP FROM THE AR-8973DS FIBULOCK IMPLANT SYSTEM DID NOT BREAK DURING THE PROCEDURE.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 22439793 ↗
• InjuryJul 8, 2025Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 07/08/2025: THE AR-8973DS FIBULOCK IMPLANT SYSTEM HAD THE END CAP IN THE KIT INSERTED INTO THE FIBULOCK NAIL DURING THE INITIAL PROCEDURE. DURING THE ROH/TTC REVISION, THE END CAP WAS REMOVED BEFORE THE EXTRACTION OF THE BROKEN FIBULAR NAIL. THE END CAP FROM THE AR-8973DS FIBULOCK IMPLANT SYSTEM DID NOT BREAK DURING THE PROCEDURE.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 22439255 ↗
• MalfunctionMay 23, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SYNDESMOSIS SURGERY WHEN THE SURGERON TRIED TO RELEASE THE BUTTON OF THE TIGHTROPE, IT DID NOT FLIP. AS HE PULLED IT, THE BUTTON GOT STUCK INSIDE THE PATIENTS BONE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE AR-8926SS. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22078990 ↗
• InjuryMay 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A PATIENT REPORTED VIA PHONE A DISLOCATION THAT REQUIRED METAL PARTS TO STABILIZE THE TIBIA. ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN RIGHT ANKLE FRACTURE PROCEDURE DURING WHICH AN AR-8943C-10 LOCKING STRAIGHT PLATE, (QTY. (B)(4)) OF AN AR-8835-14 LOW PROFILE NONLOCKING SCREW, SS, 3.5 X 14 MM, AN AR-8835-16 LOW PROFILE SCREW, SS, 3.5 X 16 MM, CORTICAL, AN AR-8840-14 LOW PROFILE SCREW, SS, 4.0 X 14 MM, CANCELLOUS, AN AR-8840-12 LOW PROFILE SCREW, SS, 4.0 X 12 MM, CANCELLOUS, (QTY. (B)(4)) OF AN AR-8925SS SYNDESMOSIS TIGHTROPE XP, STAINLESS STEEL, AND AN (QTY (B)(4)) OF AN AR-1322BNF SUTURE ANCHOR, MINI BIO-SUTURETAK 2.4 X 8.5 MM WITH 2-0 FIBERWIRE WITH TWO TAPER POINT NEEDLES WERE IMPLANTED. THE PATIENT HAS REPORTED AN ALLERGIC REACTION AFFECTING THE ENTIRE LEG INTERNALLY AND EXTERNALLY, CAUSING SIGNIFICANT SWELLING AND INTENSE PAIN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 4/15/2025: THE PATIENT IS UNABLE TO CONFIRM WHETHER THE REACTION IS ALLERGY-RELATED UNTIL THE METAL IS REMOVED, WHICH IS SCHEDULED WITHIN THE NEXT TWO WEEKS. THE PATIENT HAS A DOCUMENTED HISTORY OF SURGICAL STAINLESS STEEL ALLERGY AND A CONFIRMED NICKEL ALLERGY. NO FURTHER INFORMATION

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22056239 ↗
• MalfunctionMay 12, 2025Break; Break

  ON 04/21/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8925SS K-LESS T-ROPE WAS DAMAGED. NO FURTHER INFORMATION WAS PROVIDED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED VIA SALES REP ON 05/09/2025 THAT THE TIGHTROPE BROKE ON FINAL TENSIONING. IT BROKE AT THE BUTTON AND PULLED THROUGH AND WAS NOT TIGHT ANYMORE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003224 ↗
• MalfunctionMay 2, 2025Break; Break

  ON 04/21/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8925SS SYNDESMOSIS TIGHTROPE XP SUTURE BROKE DURING TENSIONING. ALL BROKEN SUTURES AND THE BUTTON WAS REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER AR-8925SS SYNDESMOSIS TIGHTROPE XP FROM A DIFFERENT LOT WITHOUT ISSUES. THERE WAS LESS THAN 15 MINUTES OF CASE DELAY WITH NO ADDED ANESTHESIA ADMINISTERED TO THE PATIENT. NO ADVERSE EFFECTS WERE REPORTED ON OR AFTER THE SURGERY. THIS WAS DISCOVERED DURING A SYNDESMOSIS REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950635 ↗
• InjuryApr 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A PATIENT REPORTED VIA PHONE A DISLOCATION THAT REQUIRED METAL PARTS TO STABILIZE THE TIBIA. ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN RIGHT ANKLE FRACTURE PROCEDURE DURING WHICH AN AR-8943C-10 LOCKING STRAIGHT PLATE, (QTY. 4) OF AN AR-8835-14 LOW PROFILE NONLOCKING SCREW, SS, 3.5 X 14 MM, AN AR-8835-16 LOW PROFILE SCREW, SS, 3.5 X 16 MM, CORTICAL, AN AR-8840-14 LOW PROFILE SCREW, SS, 4.0 X 14 MM, CANCELLOUS, AN AR-8840-12 LOW PROFILE SCREW, SS, 4.0 X 12 MM, CANCELLOUS, (QTY. 2) OF AN AR-8925SS SYNDESMOSIS TIGHTROPE XP, STAINLESS STEEL, AND AN (QTY 2) OF AN AR-1322BNF SUTURE ANCHOR, MINI BIO-SUTURETAK 2.4 X 8.5 MM WITH 2-0 FIBERWIRE WITH TWO TAPER POINT NEEDLES WERE IMPLANTED. THE PATIENT HAS REPORTED AN ALLERGIC REACTION AFFECTING THE ENTIRE LEG INTERNALLY AND EXTERNALLY, CAUSING SIGNIFICANT SWELLING AND INTENSE PAIN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 4/15/2025: THE PATIENT IS UNABLE TO CONFIRM WHETHER THE REACTION IS ALLERGY-RELATED UNTIL THE METAL IS REMOVED, WHICH IS SCHEDULED WITHIN THE NEXT TWO WEEKS. THE PATIENT HAS A DOCUMENTED HISTORY OF SURGICAL STAINLESS-STEEL ALLERGY AND A CONFIRMED NICKEL ALLERGY. NO FURTHER INFORMATION HAS BEEN REPOR

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21865605 ↗
• MalfunctionFeb 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A PATIENT CONTACTED CUSTOMER SERVICE REQUESTING THE MATERIAL COMPOSITION OF A RIGHT FIBULA NAIL 3.0 BY 130 MM. NO ALLEGATION OF PRODUCT DEFICIENCY OR ADVERSE EVENT WAS REPORTED WITHIN THIS INQUIRY. ON (B)(6) 2025, THE PATIENT REPORTED VIA PHONE TO HAVE BEEN EXPERIENCING DIFFICULTY WALKING AND CONSTANT PAIN. THE PATIENT STATED THAT THE SCREWS APPEAR TO BE PROTRUDING AND CAN BE SEEN ON THE SKIN OF THE KNEE. THE PATIENT UNDERWENT TIBIAL SURGERY DUE TO AN ACCIDENT ABOUT A YEAR AND A HALF AGO IN WHICH SCREWS AND THE TIBIAL NAIL WAS IMPLANTED. THE PATIENT REPORTS TO BE HIGHLY ALLERGIC TO TITANIUM; HOWEVER, POST OPERATION, THE PATIENT HAD A THREE WEEKLONG METAL TESTING, WHICH CAME BACK NEGATIVE FOR ALLERGIES. THE PATIENT WAS NOT TESTED FOR ALLERGIES PRIOR TO THE SURGERY. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 2/14/2025: IT WAS REPORTED BY THE PATIENT VIA EMAIL THAT AN AR-8973DS FIBULOCK IMPLANT SYSTEM, A 1109-300 TIBIAL NAIL, AN 8001-040 CAPTURED CORTICAL SCREW, TWO 8001-034 CAPTURED CORTICAL SCREW, TWO 8001-044 CAPTURED CORTICAL SCREW, AN AR-8973L-30-130 ARTHREX FIBULOCK NAIL, AN AR-8830-16 FULLY THREADED CANCELLOUS SCREW, AND AN AR-89

  Patient problems: Pain

  MAUDE report 21471136 ↗
• MalfunctionFeb 4, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8925SS SYNDESMOSIS TIGHTROPE XP HAD THE TENSIONING STRAND OF THE SYNDESMOSIS TIGHTROPE IMPLANT BREAK WHILE THE SURGEON WAS PERFORMING THE FINAL TENSIONING WITH THE PROVIDED HANDLES. THIS ISSUE LED TO SLACK ENTERING THE SYSTEM AND LOSING THE SYNDESMOSIS REDUCTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 1/21/2025: THIS WAS DISCOVERED DURING AN ANKLE FRACTURE WITH SYNDESMOSIS REPAIR PROCEDURE. THE AR-8925SS SYNDESMOSIS TIGHTROPE XP DID NOT BREAK IN THE PATIENT. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED. THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21306905 ↗
• MalfunctionNov 4, 2024Positioning Failure; Positioning Failure

  ON 10/18/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8925SS KNOTLESS TIGHTROPE HAD AN ISSUE DURING A PROCEDURE. THE TIGHTROPE WAS IMPLANTED WELL BUT WHEN THE TENSION WAS APPLIED THE BUTTON OF THE MEDIAL MALLEOLUS WENT THROUGH THE FRACTURE INSIDE THE BONE, AND THE DOCTOR HAD TO BITE THE SUTURE TO REMOVE IT.

  Patient problems: Insufficient Information

  MAUDE report 20600127 ↗
• MalfunctionOct 17, 2024Break; Break

  ON 10/14/2024, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-8925SS SYNDESMOSIS TIGHTROPE XP HAD AN ISSUE. WHILE TENSIONED DOWN, THE TIGHTROPE HAD THE SUTURE FRAYED AND THEN GOT TANGLED AND BUNDLED UP SO THEY COULD NOT TENSION IT FURTHER. THE BROKEN SUTURE WAS REMOVED FROM THE PATIENT, AND ANOTHER KIT WAS OPENED FROM A DIFFERENT LOT WITH NO ISSUES. THERE WAS A FIVE-MINUTE DELAY. THIS WAS DISCOVERED DURING A FIBULA FRACTURE SYNDESMOSIS REPAIR ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20469589 ↗
• MalfunctionOct 16, 2024Break; Break

  ON 10/09/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-8925SS SYNDESMOSIS TIGHTROPE BUTTON BROKE OFF THE TIP. THIS OCCURRED WHILE OPERATING ON AN ANKLE FRACTURE WHICH REQUIRED AT TIGHTROPE XP FOR SYNDESMOTIC STABILIZATION. THEY OPENED THE XP IMPLANT, AND WITHOUT IMPLANTING THE TIGHTROPE THROUGH THE DRILL TUNNEL THE BUTTON BROKE OFF THE TIP. THEY TRIED TO PLACE THE BUTTON BACK ON THE TIP BUT IT WAS SHOWING TO HAVE COMPLETELY BROKEN OFF. THE CASE CONTINUED USING ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20462881 ↗
• InjurySep 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN. ON (B)(6) 2023, THE PATIENT UNDERWENT SURGERY FOR AN ANKLE FRACTURE AND SYNDESMOSIS REPAIR. DURING THE PROCEDURE, TWO AR-8730-36PT LOW PROFILE SCREW, TI, 3.0 MM X 36 MM, CANCELLOUS, PARTIALLY THREADED, AN AR-8827-18 LOW PROFILE SCREW, 2.7 X 18 MM, CORTEX, AN AR-8827-22 LOW PROFILE SCREW, 2.7 X 22 MM, CORTEX, AN AR-8973DS FIBULOCK IMPLANT SYSTEM, AN AR-8973L-38-180 ARTHREX FIBULOCK NAIL, 3.8 X 180 MM LEFT, AND AN AR-8925SS SYNDESMOSIS TIGHTROPE XP, STAINLESS STEEL WERE IMPLANTED. POST-OPERATIVE, THE PATIENT STARTED TO EXPERIENCE PAIN. ON (B)(6) 2024, REVISION SURGERY WAS PERFORMED TO REMOVE ALL THE IMPLANTS EXCEPT FOR THE AR-8973L-38-180 ARTHREX FIBULOCK NAIL. DURING THE REMOVAL OF THE IMPLANTS, THE DISTAL END OF THE EXTRACTION TOOL OF AN AR-8973RK FIBULOCK REMOVAL KIT BROKE OFF AFTER ROUGHLY 8 MALLET STRIKES. ANOTHER AR-8973RK FIBULOCK REMOVAL KIT WAS OPENED, AND THE SAME THING OCCURRED. THE EXTRACTION TOOLS BROKE, BUT NO PIECES WERE IN THE PATIENT. THE SURGEON ELECTED TO CLOSE AND FINISH THE CASE WITH THE NAIL STILL IMPLANTED AND FELT CONFIDENT THAT THE REMOVE

  Patient problems: Pain

  MAUDE report 20156941 ↗
• MalfunctionAug 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SYNDESMOSIS LIGAMENT RUPTURE SURGERY THE SUTURE TORE AFTER INSERTING AND TIGHTENING OF THE DEVICE. 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 19939107 ↗