Arthrex® AR-1588BTB-IBRecalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00888867319677), received between Aug 24, 2021 and Apr 30, 2026 — classified as 1 injury, 50 malfunctions.

The most frequently reported specific device problem is “Break” (28 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 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Physical Resistance/Sticking

  ON (B)(6) 2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588BTB-IB TIGHTROPE II BTB¿S STATIC SUTURE IN ONE OF THE LOCKING/STITCHING MECHANISMS IS THROUGH THE WIRE LOOP AND WOULD NOT ALLOW THE WIRE SUTURE TO PULL THROUGH. THIS WAS DISCOVERED ON (B)(6) 2026 DURING AN ACL RECONSTRUCTION PROCEDURE WITH NO PATIENT HARM REPORTED. NO CASE DELAY WAS EXPERIENCED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE CASE WAS COMPLETED USING ANOTHER AR-1588BTB-IB OF A DIFFERENT LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25048316 ↗
• MalfunctionMar 31, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE LOCKING MECHANISM OF THE DEVICE JAMMED AND ONLY ONE SHORTENING SUTURE COULD BE MOVED. 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 24742463 ↗
• MalfunctionMar 31, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE LOCKING MECHANISM OF THE DEVICE JAMMED AND ONLY ONE SHORTENING SUTURE COULD BE MOVED. 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 24742459 ↗
• MalfunctionFeb 10, 2026Break

  ON 21-JAN-2026, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-1588BTB-IB TIGHTROPE II BTB IMPLANT WAS USED DURING SURGERY AND BROKE INTRAOPERATIVELY. A SECOND IMPLANT WAS THEN USED, BUT IT ALSO BROKE, REQUIRING A THIRD IMPLANT TO COMPLETE THE PROCEDURE. THIS ISSUE OCCURRED DURING AN ACL PROCEDURE PERFORMED ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 26-JAN-2026: ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING AN AR-1588BTB-IB TIGHTROPE II BTB IMPLANT. THE CASE EXPERIENCED A DELAY DUE TO THE ADDITIONAL TIME REQUIRED, BUT NO EXTRA ANESTHESIA WAS ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 24306206 ↗
• MalfunctionFeb 10, 2026Break

  ON 21-JAN-2026, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-1588BTB-IB TIGHTROPE II BTB IMPLANT WAS USED DURING SURGERY AND BROKE INTRAOPERATIVELY. A SECOND IMPLANT WAS THEN USED, BUT IT ALSO BROKE, REQUIRING A THIRD IMPLANT TO COMPLETE THE PROCEDURE. THIS ISSUE OCCURRED DURING AN ACL PROCEDURE PERFORMED ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 26-JAN-2026: ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING AN AR-1588BTB-IB TIGHTROPE II BTB IMPLANT. THE CASE EXPERIENCED A DELAY DUE TO THE ADDITIONAL TIME REQUIRED, BUT NO EXTRA ANESTHESIA WAS ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 24306085 ↗
• MalfunctionJan 8, 2026Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT DURING GRAFT PREPARATION FOR AN ACL PERFORMED ON (B)(6) 2025, AN AR-1588BTB-IB TIGHTROPE II BTB ENCOUNTERED AN ISSUE. WHILE ATTEMPTING TO CONVERT THE SUTURE THROUGH THE SPLICE OF THE BUTTON, THE BLUE FLAG/PASSER BROKE, PREVENTING THE SUTURE FROM PASSING AND COMPLETING THE CONVERSION. A SECOND BTB TIGHTROPE WAS OPENED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT HARM TO THE PATIENT OR ADDITIONAL SURGICAL TIME. ADDITIONAL INFORMATION WAS REQUESTED ON 22-DEC-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003728 ↗
• MalfunctionSep 9, 2025Break; Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (2) AR-1588BTB-IB TIGHTROPES WIRE BROKE. THIS OCCURRED DURING AN ACL RECONSTRUCTION WITH GRAFTLINK WHEN THE WIRE WAS BEING PULLED THROUGH THE WIRE AND BEING PULLED THROUGH AND BROKE. THIS OCCURRED WITH BOTH DEVICES. THE DEVICES WERE CUT OUT OF THE GRAFT, AND THE CASE CONTINUED USING AN AR-1588BTB. THE CASE WAS DELAYED ABOUT 15-20 MINUTES, AND ADDITIONAL ANESTHESIA WAS NOT REQUIRED.

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

  MAUDE report 23005861 ↗
• MalfunctionSep 9, 2025Break; Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (2) AR-1588BTB-IB TIGHTROPES WIRE BROKE. THIS OCCURRED DURING AN ACL RECONSTRUCTION WITH GRAFTLINK WHEN THE WIRE WAS BEING PULLED THROUGH THE WIRE AND BEING PULLED THROUGH AND BROKE. THIS OCCURRED WITH BOTH DEVICES. THE DEVICES WERE CUT OUT OF THE GRAFT, AND THE CASE CONTINUED USING AN AR-1588BTB. THE CASE WAS DELAYED ABOUT 15-20 MINUTES, AND ADDITIONAL ANESTHESIA WAS NOT REQUIRED.

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

  MAUDE report 23005856 ↗
• MalfunctionJul 22, 2025Failure to Advance; Defective Device; Failure to Advance; Defective Device

  ON 06/30/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-1588BTB-IB TIGHTROPE® II BTB WAS DEEMED DEFECTIVE AFTER TRYING TO SHUTTLE THE WHITE TAIL OF THE BTB TIGHTROPE THROUGH THE LOCKING MECHANISM. THIS OCCURRED DURING A REVISION ACL RECONSTRUCTION ON (B)(6) 2025. THE WHITE TAIL SUTURE WOULD NOT PASS THROUGH THE TIGHTROPE LOCKING CONFIGURATION TO CLOSE THE LOOP OF THE BTB TIGHTROPE. THEY ULTIMATELY CUT THE TIGHTROPE OFF AND LOADED A NEW ONE ON.

  Patient problems: Insufficient Information

  MAUDE report 22568183 ↗
• MalfunctionJun 16, 2025Break; Break

  ON 05/22/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588BTB-IB TIGHTROPE FINGERTRAP OF THE TIGHTROPE BROKE WHEN UNDER TENSION. THIS OCCURRED DURING USE IN A ALLOGRAFT CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212810 ↗
• MalfunctionJun 16, 2025Break; Unintended Movement; Break; Unintended Movement

  ON 05/21/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-1588BTB-IB TIGHTROPE® II BTB SUTURE BROKE. THIS OCCURRED DURING AN ACL RECONSTRUCTION THE GRAFT WAS PASSED, AND THEY BEGAN TENSIONING THE FEMORAL TIGHTROPE, AND ONE OF THE SUTURES BROKE, CAUSING THE TIGHTROPE TO SLIDE FREELY AND NO LONGER TENSION. A SECOND ONE WAS OPENED, THE SAME ISSUE OCCURRED AT THE SAME PLACE. THEY OPENED AN AR-1588BTB AND WERE ABLE TO SECURELY IMPLANT THE GRAFT. TOTAL DELAY WAS ABOUT 15 MINUTES. THE CASE ENDED WITH NO OTHER ISSUES. EVERYTHING FROM THE DEFECTIVE TIGHTROPE WAS REMOVED FROM THE PATIENT. TIGHTROPES WERE CUT UP AND USED FOR SHUTTLE STITCHES.

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

  MAUDE report 22210849 ↗
• InjuryJun 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A PATIENT RETURNED TO THE OPERATING ROOM FOR THE REMOVAL OF SURGICAL HARDWARE DUE TO COMPLICATIONS FOLLOWING AN ARTHROSCOPIC ACL RECONSTRUCTION PERFORMED APPROXIMATELY 6¿8 WEEKS AGO. ACCORDING TO THE SURGEON, THE PATIENT HAD BEEN RECOVERING WELL UNTIL TWO WEEKS AGO WHEN DRAINAGE WAS NOTED FROM THE TIBIAL INCISION. IN RESPONSE, THE PATIENT UNDERWENT AN OPERATIVE KNEE WASHOUT, THOUGH NO HARDWARE WAS REMOVED AT THAT TIME. FOLLOWING CONTINUED COMPLAINTS OF RECURRENT TIBIAL DRAINAGE AFTER THE WASHOUT, THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2025. DURING THE PROCEDURE, THE AR-2324PSL 4.75 PEEK-SWIVELOCK C, WAS FULLY REMOVED FROM THE TIBIA, ALONG WITH THE DISTAL PORTION OF THE INTERNALBRACE SUTURE. THE IMPLANT WAS SENT OUT FOR A CULTURE. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 4/24/2025: THE ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2025. BOTH PROCEDURES WERE PERFORMED BY THE SAME SURGEON. THE INFECTION IDENTIFIED WAS MSSA. ADDITIONAL INFORMATION RECEIVED ON 5/16/2025: DURING THE REVISION SURGERY, ONLY THE AR-2324PSLC AND A SMALL PORTION OF THE AR-1588BTB-IB TIGHTROPE II B

  Patient problems: Unspecified Infection

  MAUDE report 22166118 ↗
• MalfunctionMar 13, 2025Break; Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT QTY. 2 OF AN AR-1588BTB-IB TIGHTROPE II BTB HAD AN ISSUE DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025. WHEN THE SURGEON TRIED TO USE THE DEVICE, THE LOCKING SUTURE MECHANISM RIPPED INSIDE THE PATIENT; IT BROKE THE TIGHTROPE. THAT HAPPENED TWICE IN A ROW. NOTHING BROKE INSIDE THE PATIENT, ONLY THE SUTURES, AND THERE WAS NO HARM TO THE PATIENT. EACH TIME, THE WHOLE IMPLANT SYSTEM WAS REMOVED FROM THE PATIENT. BOTH COMPLAINT DEVICES WERE DISCARDED BUT A PICTURE WAS TAKEN. ANOTHER AR-1588BTB-IB TIGHTROPE II BTB WITH LOT NUMBER 15346826 WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A CASE DELAY OF 20 MINUTES AND IT COULD NOT BE CONFIRMED IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593996 ↗
• MalfunctionMar 13, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT QTY. 2 OF AN AR-1588BTB-IB TIGHTROPE II BTB HAD AN ISSUE DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025. WHEN THE SURGEON TRIED TO USE THE DEVICE, THE LOCKING SUTURE MECHANISM RIPPED INSIDE THE PATIENT; IT BROKE THE TIGHTROPE. THAT HAPPENED TWICE IN A ROW. NOTHING BROKE INSIDE THE PATIENT, ONLY THE SUTURES, AND THERE WAS NO HARM TO THE PATIENT. EACH TIME, THE WHOLE IMPLANT SYSTEM WAS REMOVED FROM THE PATIENT. BOTH COMPLAINT DEVICES WERE DISCARDED BUT A PICTURE WAS TAKEN. ANOTHER AR-1588BTB-IB TIGHTROPE II BTB WITH LOT NUMBER 15346826 WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A CASE DELAY OF 20 MINUTES AND IT COULD NOT BE CONFIRMED IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593931 ↗
• MalfunctionFeb 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT (QTY. 2) OF AN AR-1588BTB-IB TIGHTROPE II BTB HAD THE SAME FAILURE WHEN THE PA WAS RE-TENSIONING THE BTB TIGHTROBE AFTER CYCLING THE KNEE. THE SURGEON DRILLED THE TIBIA AND FEMUR SOCKETS WITH A FLIPCUTTER 3. THE IMPLANT WAS PASSED INTO THE FEMUR; AN X-RAY WAS TAKEN TO CONFIRM THE BUTTON ON THE CORTEX, AND WHITE TAILS WERE TENSIONED TO BRING THE GRAFT INTO THE FEMORAL SOCKET. THE TIBIA SIDE WAS THEN PASSED, THE BUTTON ATTACHED AND TIGHTENED DOWN ON THE TIBIA SIDE. THE SURGEON CYCLED THE KNEE AND RE-TENSIONED THE TIBIA. THEN, WHEN THE PA TENSIONED THE FEMUR ONE LAST TIME AND NOTICED THE WHITE TENSIONING TAILS FELT OFF. THE SURGEON PROBED THE GRAFT, AND IT EASILY CAME OUT OF THE FEMORAL TUNNEL. THE SURGEON HAD TO CUT OUT THE TIBIA SUTURE AND PULL THE GRAFT OUT OF THE MEDIAL PORTAL. THE GRAFT WAS NOT SALVAGEABLE, SO THEY HAD TO GET A NEW ALLOGRAFT GRAFTLINK. THE SAME ISSUE OCCURRED AFTER THE SAME STEPS WERE RETAKEN WITH THE SECOND AR-1588BTB-IB TIGHTROPE II BTB USED. AFTER CYCLING THE KNEE THIS TIME, THEY NOTICED THAT THE METAL BUTTON COULD SLIDE WHEREVER IT WANTED ON THE TWO WHITETAILS, BUT THE IMPLANT WAS STILL SECURED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445971 ↗
• MalfunctionFeb 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 01/31/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT (QTY. 2) OF AN AR-1588BTB-IB TIGHTROPE II BTB HAD THE SAME FAILURE WHEN THE PA WAS RE-TENSIONING THE BTB TIGHTROBE AFTER CYCLING THE KNEE. THE SURGEON DRILLED THE TIBIA AND FEMUR SOCKETS WITH A FLIPCUTTER 3. THE IMPLANT WAS PASSED INTO THE FEMUR; AN X-RAY WAS TAKEN TO CONFIRM THE BUTTON ON THE CORTEX, AND WHITE TAILS WERE TENSIONED TO BRING THE GRAFT INTO THE FEMORAL SOCKET. THE TIBIA SIDE WAS THEN PASSED, THE BUTTON ATTACHED AND TIGHTENED DOWN ON THE TIBIA SIDE. THE SURGEON CYCLED THE KNEE AND RE-TENSIONED THE TIBIA. THEN, WHEN THE PA TENSIONED THE FEMUR ONE LAST TIME AND NOTICED THE WHITE TENSIONING TAILS FELT OFF. THE SURGEON PROBED THE GRAFT, AND IT EASILY CAME OUT OF THE FEMORAL TUNNEL. THE SURGEON HAD TO CUT OUT THE TIBIA SUTURE AND PULL THE GRAFT OUT OF THE MEDIAL PORTAL. THE GRAFT WAS NOT SALVAGEABLE, SO THEY HAD TO GET A NEW ALLOGRAFT GRAFTLINK. THE SAME ISSUE OCCURRED AFTER THE SAME STEPS WERE RETAKEN WITH THE SECOND AR-1588BTB-IB TIGHTROPE II BTB USED. AFTER CYCLING THE KNEE THIS TIME, THEY NOTICED THAT THE METAL BUTTON COULD SLIDE WHEREVER IT WANTED ON THE TWO WHITETAILS, BUT THE IMPLANT WAS STILL SECURED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445967 ↗
• MalfunctionFeb 10, 2025Break; Break

  ON 01/22/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1588BTB-IB TIGHTROPE II BTB FAILED WHILE TENSIONING THE GRAFT AND SEEMED TO SNAP UNDER MINIMAL PRESSURE. NOTHING BROKE INSIDE THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY USING ANOTHER AR-1588BTB-IB TIGHTROPE II BTB WITHOUT ISSUES. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 1/28/2025: THIS OCCURRED WHEN DOCKING THE GRAFT INTO THE FEMORAL TUNNEL; THERE WAS A SNAP SOUND, AND THE TIGHTROPE CAME RIGHT OUT. THE KNOTLESS MECHANISM LOOKED COMPLETELY TORN AND SHREDDED. THE CASE WAS DELAYED TEN MINUTES; HOWEVER, THE SALES REPRESENTATIVE WAS UNSURE IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE CASE WAS COMPLETED BY USING THE INTERNALBRACE FROM THE FIRST TIGHTROPE TO PASS THE SECOND AR-1588BTB-IB TIGHTROPE II BTB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349433 ↗
• MalfunctionNov 26, 2024Break; Break

  ON 11/04/2024, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1588BTB-IB TIGHTROPE II BTB AND AN AR-1588R-IB ACL REPAIR TIGHTROPE BROKE AT THE BUTTON UPON TENSIONING. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT, AND THE CASE WAS COMPLETED WITH ANOTHER AR-1588R-IB ACL REPAIR TIGHTROPE FROM THE SAME LOT. AS A PRECAUTION, THE SURGEON DID NOT TENSION THE TIGHTROPE TOO TIGHTLY AND PUT A SCREW IN TO HOLD IT SECURELY. THERE WAS A 30-MINUTE CASE DELAY WITH ADDITIONAL ANESTHESIA ADMINISTERED TO THE PATIENT. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20779614 ↗
• MalfunctionNov 6, 2024Break; Break

  ADDITIONAL INFORMATION WAS PROVIDED ON 10/28/2024 BY AN ARTHREX EMPLOYEE WHO STATED THAT THE EVENT OCCURRED ON (B)(6) 2024. PROCEDURE PERFORMED WAS A ACL ALLOGRAFT RECONSTRUCTION. THE DEVICE BROKE WHILE PULLING THROUGH THE FEMORAL TUNNEL AND TIGHTENING WHITE SUTURES. NO PHOTOS WERE TAKEN. AN ARTHREX REP WAS PRESENT. THE PATIENT'S BONE QUALITY WAS SOFTER. A FLIPCUTTER 3 WAS USED TO COMPLETE THE PROCEDURE. ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS DELAYED BY AN HOUR. NO ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 20619535 ↗
• MalfunctionOct 11, 2024Break; Break

  ON 10/3/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-1588BTB-IB TIGHTROPE II BTB WOULD NOT PASS SMOOTHLY AT ALL AFTER IT WAS PASSED THROUGH THE BONE BLOCK, THE LOOP, AND THEN THE WIRE LOOP TO PASS THROUGH THE TIGHTROPE MECHANISM. THE WIRE ENDED UP BREAKING, SO A SECOND TIGHTROPE WAS OPENED. FOLLOWING THE SAME STEPS, THE SECOND AR-1588BTB-IB TIGHTROPE II BTB PASSED WITH EASE THROUGH THE MECHANISM, AND THE CASE WAS COMPLETED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 20428697 ↗
• MalfunctionOct 4, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE SUTURE PASSER NITINOL WIRE FROM AN AR-1588BTB-IB TIGHTROPE II BTB RECONSTRUCTION WITH INTERNALBRACE LIGAMENT AUGMENTATION REPAIR KIT BROKE AS THE SUTURE TAIL WAS BEING PASSED THROUGH. THE CASE WAS COMPLETED USING ANOTHER TIGHTROPE ON THE OTHER SIDE OF THE GRAFT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 20369810 ↗
• MalfunctionSep 4, 2024Break; Break

  ON 08/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588BTB-IB TIGHTROPE II BTB TENSION SUTURE BROKE AS THE GRAFT WAS PASSED THROUGH THE BONE TUNNEL OF THE FEMUR. THE GRAFT WAS REMOVED AND A NEW AR-1588BTB-I TIGHTROPE II BTB WAS USED TO PREP THE GRAFT. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 20135880 ↗
• MalfunctionAug 7, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 07/31/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588BTB-IB TIGHTROPE II BTB SUTURES WERE BROKEN. THE SURGEON SUCCESSFULLY PASSED THE GRAFT, AND THE BUTTON FLIPPED ON THE FEMORAL CORTEX. AFTER THE GRAFT WAS TENSIONED AND THE FIBERTAPE FROM THE INTERNALBRACE WAS INSERTED WITH A SWIVELOCK, A LOOK INTO THE JOINT SHOWED THAT TWO SUTURES WERE RIPPED. THE SURGEON CUT THE TAILS REMAINING IN THE JOINT AND NO HARM TO THE PATIENT WAS DONE. THE SURGEON SUSPECTS THE SUTURES FAILED AT THE BUTTON APERTURE ON THE FEMORAL SIDE. THE BUTTON WAS LEFT IMPLANTED IN THE PATIENT, AND THE SURGEON DECIDED TO FORGO USING THE INTERNAL BRACE FEATURE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 19927937 ↗
• MalfunctionJun 27, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE TORE WHILE TIGHTENING THE LOOP. THE SUTURE TORE DURING IMPLANT INSERTION. 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 19628726 ↗
• MalfunctionJun 20, 2024Failure to Advance; Failure to Advance

  ON 2/7/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588BTB-IB TIGHTROPE II BTB WOULDN'T SLIDE ONCE LOADED AND WAS UNABLE TO TENSION. ANOTHER AR-1588BTB-IB TIGHTROPE II BTB WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN ACL GRAFTLINK PROCEDURE ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575029 ↗