Arthrex® AR-1588TN-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00888867371897), received between Aug 17, 2022 and May 22, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURES BROKE DURING TIGHTENING OF THE IMPLANT. 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 25253881 ↗
• MalfunctionMar 3, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY DURING THE PASSAGE OF THE GRAFT INTO THE FEMORAL CANAL, THE SUTURE FROM THE TIGHTROPE II RT IMPLANT AR-1588RT-2J TORE. IT WAS NECESSARY TO RE-SUTURE THE GRAFT AND USE OTHER IMPLANTS (INCLUDING THOSE IN THE TIBIAL CANAL). EVERYTHING WAS PERFORMED ACCORDING TO THE TECHNIQUE. 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. UPDATE 17-FEB-2026 IT WAS FURTHER REPORTED THAT ALL THREE DEVICES TORE AND WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496115 ↗
• MalfunctionFeb 2, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE OF THE DEVICE 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 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 24233902 ↗
• MalfunctionJan 12, 2026Failure to Advance

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE COULD NOT BE PULLED CORRECTLY. 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 24036696 ↗
• MalfunctionDec 19, 2025Break; Break

  ON 11/25/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT A KNEE ARTHROSCOPY WITH ACL RECONSTRUCTION PERFORMED ON (B)(6) 2025 EXPERIENCED MULTIPLE DEVICE ISSUES. TWO BUTTONS, RTJ 2 AND ABS 2, WERE INITIALLY PREPARED FOR AN ALL-INSIDE TECHNIQUE. DURING GRAFT PASSAGE, THE RTJ 2 BUTTON BECAME STUCK IN THE TIBIAL TUNNEL AND BROKE, REQUIRING REMOVAL. A BTB 2-BUTTON WAS THEN OPENED, BUT ITS SUTURES APPEARED FRAYED AND DAMAGED DESPITE BEING NEW. WHILE ASSEMBLING THE GRAFT AND APPLYING TRACTION, THE PRIMARY SUTURE BROKE, COMPROMISING THE GRAFT. A THIRD BUTTON, RTJ 1, WAS USED, AND THE GRAFT WAS RE-PREPARED. THESE ISSUES CAUSED DELAYS THAT IMPACTED CASE TIMING. THE PROCEDURE WAS ULTIMATELY COMPLETED USING AN ALTERNATIVE DEVICE. PHOTOS OF THE DAMAGED SUTURES AND BROKEN LOOP WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23848185 ↗
• MalfunctionDec 16, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY DURING THE INSERTION OF THE GRAFT INTO THE TIGHTROPE FEMORAL TUNNEL, THE DEVICE BROKE DESPITE BEING MEASURED ACCORDING TO THE TECHNIQUE, THE TUNNEL WIDTH WAS CONSISTENT WITH THE THICKNESS OF THE GRAFT. 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 23818747 ↗
• MalfunctionOct 30, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE 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 23426341 ↗
• MalfunctionAug 22, 2025Break; Break

  ON 08/04/2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-1588TN-20 TIGHTROPE II ABS, IMPLANT BROKE WHILE TENSION WAS BEING APPLIED. THE CASE WAS COMPLETED WITH A NEW PRODUCT. THIS WAS DISCOVERED DURING AN LCA PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 08/08/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22872667 ↗
• MalfunctionAug 13, 2025Damaged Thread; Damaged Thread

  IT WAS REPORTED DURING THE ANTERIOR CRUCIATE LIGAMENT SURGERY THAT THE THREADS BROKE DURING THE IMPLANT INSERTION. THE BROKEN PIECES 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 22793194 ↗
• MalfunctionJul 10, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY, THE CHINESE TRAP 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. UPDATE DW 17-JUN-2025: FURTHER INFORMATION WAS PROVIDED THAT THE REPORTED DEVICE TORE WHILE IT WAS TIGHTENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467383 ↗
• MalfunctionMay 8, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE TIGHTROPE TORE DURING TENSIONING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (A FASTTHREAD SCREW). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986355 ↗
• MalfunctionMay 5, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 04/07/2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-1588TN-20 TIGHTROPE II ABS HAD ONE STRAND THAT APPEARED BLOCKED AND COULD NOT BE PULLED TO TENSION THE TIGHTROPE. DUE TO THIS, THE TIGHTROPE WAS CUT, AND THE PROCEDURE WAS COMPLETED USING A SCREW FOR TIBIAL FIXATION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21963605 ↗
• MalfunctionFeb 11, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE OF THE DEVICE BROKE WHILE TIGHTENING THE LOOP. 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 21356273 ↗
• MalfunctionNov 6, 2024Failure to Advance; Failure to Advance

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588TN-20 TIGHTROPE® II ABS, IMPLANT WAS REPORTED TO HAVE FAILED DURING USE. THIS OCCURRED ON (B)(6) 2024 IN(B)(6) HOSPITAL DURING A QUAD ACL RECONSTRUCTION. IT WAS REPORTED THE TIGHTROPE WAS LOADED ONTO A 14MM BUTTON AND THE SURGEON ATTEMPTED TO TENSION THE TIGHTROPE DOWN TO THE BUTTON. ONE SIDE SHORTENED, THE SECOND SIDE WOULD NOT SHORTEN. TRACTION OF THE SUTURE ABOVE THE BUTTON TO NO AVAIL. THE SURGEON ENDED UP TYING THE TIGHTROPE OVER THE BUTTON AND PUTTING IN A SWIVELOCK TO BACK THE ACL UP. THE CASE WAS COMPLETED SUCCESSFULLY USING AN ADDITIONAL POINT OF FIXATION WAS USED WITH A SWIVELOCK IN THE TIBIA. THERE WAS CASE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20619982 ↗
• MalfunctionOct 2, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE SUTURE BROKE WHILE TIGHTENING THE LOOP. 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 20353486 ↗
• MalfunctionJun 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 1/19/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588TN-20 TIGHTROPE II ABS SUTURE WAS DAMAGED AND COULD NOT BE USED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477727 ↗
• MalfunctionMay 17, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE TIGHTROPE THORE WHEN IT WAS PULLED THROUGH THE FEMURAL TUNNEL. 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 19342288 ↗
• MalfunctionMay 17, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588TN-2 TIGHTROPE WOULD NOT CINCH DOWN. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339815 ↗
• MalfunctionMay 9, 2024Positioning Failure; Positioning Failure

  ON 2/11/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588TN-20 TIGHTROPE II ABS WOULD NOT SEAT AND COULD NOT BE TIGHTENED DOWN. SURGEON OPENED AN AR-1588TN-21 TIGHTROPE TO COMPLETE THE PROCEDURE SUCCESSFULLY. THIS WAS DISCOVERED DURING AN ACL PROCEDURE ON (B)(6) 2022. NO FURTHER ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19277402 ↗
• MalfunctionMay 1, 2024Defective Device; Defective Device

  ON 12/28/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588TN-20 ABS TIGHTROPE CINCHING MECHANISM WAS NOT WORKING AND A KNOT WAS CREATED. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2021. SURGEON REMOVED THE IMPLANT AND A NEW TIGHTROPE WAS ATTACHED TO THE GRAFT AND IMPLANTED SUCCESSFULLY INTO PATIENT WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220729 ↗
• InjuryJun 19, 2023Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  ON 05/24/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588TN-20 TIGHTROPE IMPLANT WOULD NOT TIGHTEN . THIS WAS DISCOVERED DURING A CASE. SURGEON DIVERTED FROM INTENDED PROCEDURE TO USE A SWIVELLOCK TO COMPLETE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17152444 ↗
• MalfunctionJan 30, 2023Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REP VIA EMAIL THAT AN AR-1588TN-20, TIGHTROPE® II ABS, IMPLANT SNAPPED AT THE LOOP WHEN TENSIONING TIBIA USING TENSIONING HANDLES. THIS WAS DISCOVERED DURING USE AND A CASE WAS INVOLVED. TO COMPLETE THE PROCEDURE, THE GRAFT WAS REMOVED FROM THE JOINT AND SALVAGED WITH 2X AR-1588BTB TIGHTROPES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16263650 ↗
• MalfunctionAug 17, 2022Break

  IT WAS REPORTED THAT DURING A ANTERIOR CRUCIATE LIGAMENT SURGERY THE ABS LOOP WAS DAMAGED. THE THREAD WAS BROKEN WHILE INTRODUCING THE GRAFT. 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 15242710 ↗