Arthrex® AR-1588RTT2Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00888867426672), received between Dec 5, 2023 and Sep 9, 2026 — classified as 51 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. 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.

• MalfunctionSep 9, 2026Material Split, Cut or Torn

  It was reported that during an anterior cruciate ligament surgery the suture tore during tensioning. 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 50691380 ↗
• MalfunctionSep 8, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50673277 ↗
• MalfunctionSep 8, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50673130 ↗
• MalfunctionSep 8, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50672967 ↗
• MalfunctionSep 8, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50671457 ↗
• MalfunctionJul 30, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50083545 ↗
• MalfunctionMay 22, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SHUTTLE SUTURE TORE DURING INSERTION. 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 25257718 ↗
• MalfunctionMay 22, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE TORE WHILE TIGHTENING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE PART NUMBER AR-1588BTB2. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256668 ↗
• MalfunctionApr 29, 2026Break

  ON 10-APR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588RTT2 FIBERTAG TIGHTROPE'S LOCKING MECHANISM ON THE BUTTON BROKE WHEN TENSIONING. NO PARTS OR FRAGMENTS WERE IDENTIFIED WHEN THE ISSUE OCCURRED. THE DEVICE WAS REPLACED WITH ANOTHER AR-1588RTT2 TIGHTROPE TO COMPLETE THE CASE. THE ISSUE CAUSED A 10-MINUTE DELAY, IN WHICH THE GRAFT HAD TO BE REMOVED AND REPLACED. THIS OCCURRED DURING USE IN AN ACL RECONSTRUCTION CASE ON (B)(6) 2026. THERE WAS NO PATIENT IMPACT OR ADDITIONAL ANESTHESIA ADMINISTERED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031955 ↗
• MalfunctionMar 26, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT WITH A QUADRICEPS TENDON, THE WHITE SUTURE OF THE TIGHTROPE TORN DURING TENSIONING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH A DIFFERENT DEVICE (AR-1588TNT2). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699224 ↗
• MalfunctionMar 10, 2026Break

  ON (B)(6), A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-1558RTT2 FIBERTAG TIGHTROPE II IMPLANTS AND ONE AR-1588RT-2J TIGHTROPE II RT WITH DEPLOYING SUTURE BROKE BETWEEN THE TWO BUTTON HOLES DURING TENSIONING ON THE FEMORAL SIDE OF AN ACL RECONSTRUCTION. THE PROCEDURE WAS COMPLETED USING POST-AND-WASHER FIXATION ON BOTH THE FEMUR AND TIBIA. THIS ISSUE WAS DISCOVERED INTRAOPERATIVELY ON (B)(6), WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6): THE CASE WAS COMPLETES USING PRODUCTS FROM ANOTHER MANUFACTURER. ALL THREE FAILED IMPLANTS WERE REMOVED FROM THE PATIENT. THE SURGERY EXPERIENCED AN APPROXIMATE 1.5-HOUR DELAY. NO INCREASE IN THE LEVEL OF ANESTHESIA WAS REPORTED; HOWEVER, ANESTHESIA DURATION WAS PROLONGED DUE TO THE EXTENDED SURGICAL TIME. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6): THE PROCEDURE DURATION WAS EXTENDED BY APPROXIMATELY 1.5 HOURS DUE TO THE REPORTED DEVICE ISSUE. THE ANESTHESIA TIME WAS PROLONGED BECAUSE ADDITIONAL TIME WAS NEEDED TO ADDRESS AND RESOLVE THE PRODUCT MALFUNCTION TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563344 ↗
• MalfunctionMar 10, 2026Break

  ON 18-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-1558RTT2 FIBERTAG TIGHTROPE II IMPLANTS AND ONE AR-1588RT-2J TIGHTROPE II RT WITH DEPLOYING SUTURE BROKE BETWEEN THE TWO BUTTONHOLES DURING TENSIONING ON THE FEMORAL SIDE OF AN ACL RECONSTRUCTION. THE PROCEDURE WAS COMPLETED USING POST-AND-WASHER FIXATION ON BOTH THE FEMUR AND TIBIA. THIS ISSUE WAS DISCOVERED INTRAOPERATIVELY ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 24-FEB-2026: THE CASE WAS COMPLETED USING PRODUCTS FROM ANOTHER MANUFACTURER. ALL THREE FAILED IMPLANTS WERE REMOVED FROM THE PATIENT. THE SURGERY EXPERIENCED AN APPROXIMATE 1.5-HOUR DELAY. NO INCREASE IN THE LEVEL OF ANESTHESIA WAS REPORTED; HOWEVER, ANESTHESIA DURATION WAS PROLONGED DUE TO THE EXTENDED SURGICAL TIME. ADDITIONAL INFORMATION WAS RECEIVED ON 05-MAR-2026: THE PROCEDURE DURATION WAS EXTENDED BY APPROXIMATELY 1.5 HOURS DUE TO THE REPORTED DEVICE ISSUE. THE ANESTHESIA TIME WAS PROLONGED BECAUSE ADDITIONAL TIME WAS NEEDED TO ADDRESS AND RESOLVE THE PRODUCT MALFUNCTION TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563236 ↗
• MalfunctionFeb 11, 2026Break

  ON 22-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588RTT2 FIBERTAG TIGHTROPE II FEMORAL TIGHTROPE SUTURE RUPTURED DURING FINAL TENSIONING. THIS ISSUE WAS DISCOVERED DURING A QUAD ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 26-JAN-2026: THE EVENT OCCURRED INTRAOPERATIVELY WHILE THE DEVICE WAS IN USE WITHIN THE PATIENT. AS A RESULT, THE TIGHTROPE AND BUTTON WERE REMOVED. THE PROCEDURE WAS COMPLETED BY PASSING A FIBERLINK AND UTILIZING A BTB TIGHTROPE TO RECONSTRUCT THE FEMORAL TIGHTROPE CONSTRUCT WITHOUT REMOVING THE GRAFT FROM THE TUNNEL, USING AN AR-1588BTB-IB TIGHTROPE II BTB. THE SURGERY WAS PROLONGED BY APPROXIMATELY 20¿30 MINUTES, AND ADDITIONAL ANESTHESIA WAS REQUIRED DUE TO THE PROCEDURAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312892 ↗
• MalfunctionFeb 4, 2026Material Rupture

  IT WAS REPORTED THAT DURING THE ALL-INSIDE ANTERIOR CRUCIATE LIGAMENT SURGERY, THE FEMORAL SUTURE OF THE TIGHTROPE RUPTURED, AND THE SYSTEM COULD NO LONGER BE TENSIONED. NO TORN PIECES REMAINED IN 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 24256666 ↗
• MalfunctionJan 26, 2026Break

  ON 09-JAN-2026, A DISTRIBUTOR REPORTED VIA EMAIL THAT THE TIGHTROPE LOOP BROKE ON AN AR-1588RTT2 FIBERTAG TIGHTROPE II IMPLANT WHILE PASSING THE GRAFT THROUGH THE FEMORAL TUNNEL. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE ON(B)(6) 2026, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 21-JAN-2026: THE BROKEN TIGHTROPE LOOP WAS RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED WITH A NON-ARTHREX PRODUCT. THE CASE WAS DELAYED FIVE MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177687 ↗
• MalfunctionJan 20, 2026Break

  ON 6TH JANUARY 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1588RTT2, FIBERTAG® TIGHTROPE® II IMPLANT, THE RTT FIBERTAG TIGHTROPE SNAPPED AT THE BUTTON AFTER THE BUTTON HAD FLIPPED ON OUTER CORTEX. THE SURGEON WENT TO DOCK IN GRAFT, AND ONE TAIL GAVE WAY AND WAS UNABLE TO TENSION THAT SIDE. THIS WAS DETECTED DURING A QUADS ACL PROCEDURE ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A BTB TIGHTROPE WAS USED TO RECREATE THE TIGHTROPE AS THE TAG WAS FINE, ONLY THE LOCKING MECHANISM HAD FAILED ON ONE SIDE.

  Patient problems: Insufficient Information

  MAUDE report 24114662 ↗
• MalfunctionJan 2, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ALL INSIDE ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE TORE TIBIALLY WHILE INSERTION INTO THE BONE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IN ADDITION, A SCREW WAS USED TO SECURE THE TIGHTROPE. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943990 ↗
• MalfunctionDec 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ALL-INSIDE KNEE ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION SURGERY USING AUTOGRAFT QUAD TENDON WHILE INSERTING THE GRAFT IN THE TIBIAL TUNNEL AND TIGHTENING THE TIGHT ROPE (AR-1588RTT2), THE LOOP OF THE BUTTON TORE, AND THE SURGEON EVENTUALLY HAD TO ANCHOR THE THIGHTROPE STRINGS WITH A SWIVELOCK 4.75 DEVICE (AR-2324BCC). PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT 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 23862951 ↗
• MalfunctionNov 24, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SURGEON HAD A PROBLEM WITH THE TIGHTROPE. IN THE FINAL STAGE, WHEN THE TIGHTROPE WAS TENSIONED, THE LOCKING MECHANISM WAS GETTING LOOSE AND THE TIGHTROPE NO LONGER MADE TENSION SO IT DIDN'T WORK. 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 23630721 ↗
• MalfunctionNov 3, 2025Break; Break

  ON 10/29/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1588RTT2 FIBERTAG TIGHTROPE II IMPLANT BROKE DURING INSERTION. ALL BROKEN SUTURE COMPONENTS WERE REMOVED FROM THE PATIENT. THE CASE WAS DELAYED THIRTY TO FORTY MINUTES. NO FURTHER DETAILS WERE PROVIDED OVER THE PHONE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/29/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451985 ↗
• MalfunctionOct 17, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE TORE NEAR THE TOP OF THE BUTTON. 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: Foreign Body In Patient

  MAUDE report 23323078 ↗
• MalfunctionOct 15, 2025Break; Break

  ON 10/06/2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-1588RTT2 FIBERTAG TIGHTROPE II IMPLANT SNAPPED AT THE BUTTON DURING FINAL TENSIONING. NO ADDITIONAL DETAILS WERE PROVIDED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 10/08/2025: THIS OCCURRED INSIDE THE PATIENT DURING FINAL TENSIONING. ALL FRAGMENTS WERE RETRIEVED FROM THE SURGICAL SITE. THE CASE WAS COMPLETED USING ANOTHER AR-1588RTT2 FIBERTAG TIGHTROPE II IMPLANT, AND THE GRAFT WAS RE-STITCHED AND IMPLANTED WITHOUT ISSUE. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 30 MINUTES, BUT NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED. THIS EVENT OCCURRED DURING A QUAD TENDON ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303302 ↗
• MalfunctionAug 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE DEVICE TORE DURING TOGGLING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-1588BTB-2J). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885582 ↗
• MalfunctionAug 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A POSTERIOR CRUCIATE LIGAMENT AND MEDIAL COLLATERAL LIGAMENT SURGERY THE NEEDLE DETACHED FROM THE SUTURE DURING THE SECOND STITCH. 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 22770908 ↗
• MalfunctionAug 6, 2025Unintended Movement; Unintended Movement

  ON 07/17/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1588RTT2 FIBERTAG TIGHTROPE II IMPLANT ENCOUNTERED AN ISSUE DURING A QUADRUPLE ACL RECONSTRUCTION PROCEDURE PERFORMED ON (B)(6) 2025. DURING GRAFT PREPARATION, AN AR-1588RTT2 AND AR-1588TNT2 DEVICE WERE USED. THE GRAFT WAS SUCCESSFULLY SHUTTLED INTO THE PATIENT'S KNEE, AND THE TIGHTROPE BUTTON WAS FLIPPED ONTO THE FEMORAL CORTEX. HOWEVER, WHEN THE SURGEON ATTEMPTED TO TOGGLE THE WHITE STRANDS OF THE TIGHTROPE TO ADVANCE THE GRAFT INTO THE FEMORAL TUNNEL, THE STRANDS TOGGLED BACK AND FORTH WITHOUT MOVING THE GRAFT. UPON FURTHER INSPECTION, IT WAS DETERMINED THAT THE LOCKING MECHANISM ON TOP OF THE BUTTON HAD FAILED AND PULLED THROUGH, PREVENTING SUCCESSFUL GRAFT PLACEMENT. AS A RESULT, THE GRAFT HAD TO BE REMOVED THROUGH THE TIBIAL TUNNEL, AND THE BUTTON WAS RETRIEVED FROM THE LATERAL ASPECT OF THE PATIENT'S KNEE. A NEW AR-1588RTT2 DEVICE WAS OPENED, THE QUAD TENDON GRAFT WAS RE-PREPARED, AND THE PROCEDURE WAS ABLE TO PROCEED WITHOUT FURTHER COMPLICATION. ADDITIONAL INFORMATION WAS RECEIVED ON 07/29/2025: THE SURGERY WAS BRIEFLY DELAYED DUE TO RE-PREPARATION OF THE GRAFT, ADDING 15¿20 MINUTES TO THE CASE AND REQUIRI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730360 ↗