Arthrex® AR-1588TN-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00888867371903), received between Nov 15, 2021 and Mar 19, 2026 — classified as 44 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (13 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 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ALLOGRAFT ANTERIOR CRUCIATE LIGAMENT SURGERY WITH ARTHREX PRE-SUTURED GRAFTLINK ALLOGRAFT SURGERY ALL 4 DEVICES AR-1588TN-21 (LOT: 15394802, 15406295 X2, 15466001) FAILED. THE LOCKING MECHANISM JAMMED AND ONLY ONE SHORTENING SUTURE WOULD SLIDE. 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 24640381 ↗
• MalfunctionMar 19, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ALLOGRAFT ANTERIOR CRUCIATE LIGAMENT SURGERY WITH ARTHREX PRE-SUTURED GRAFTLINK ALLOGRAFT SURGERY ALL 4 DEVICES AR-1588TN-21 (LOT: 15394802, 15406295 X2, 15466001) FAILED. THE LOCKING MECHANISM JAMMED AND ONLY ONE SHORTENING SUTURE WOULD SLIDE. 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 24640380 ↗
• MalfunctionMar 19, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ALLOGRAFT ANTERIOR CRUCIATE LIGAMENT SURGERY WITH ARTHREX PRE-SUTURED GRAFTLINK ALLOGRAFT SURGERY ALL 4 DEVICES AR-1588TN-21 (LOT: 15394802, 15406295 X2, 15466001) FAILED. THE LOCKING MECHANISM JAMMED AND ONLY ONE SHORTENING SUTURE WOULD SLIDE. 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 24640354 ↗
• MalfunctionMar 19, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ALLOGRAFT ANTERIOR CRUCIATE LIGAMENT SURGERY WITH ARTHREX PRE-SUTURED GRAFTLINK ALLOGRAFT SURGERY ALL 4 DEVICES AR-1588TN-21 (LOT: 15394802, 15406295 X2, 15466001) FAILED. THE LOCKING MECHANISM JAMMED AND ONLY ONE SHORTENING SUTURE WOULD SLIDE. 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 24640319 ↗
• MalfunctionMay 15, 2025Break; Break

  ON 04/22/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1588TN-21 TIGHTROPE II ABS BROKE WITH MINIMAL TENSION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, AND NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22025137 ↗
• MalfunctionFeb 7, 2025Difficult to Advance; Difficult to Advance

  ON 01/22/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588TN-21 TIGHTROPE WAS THREADED THROUGH THE GRAFT AND BUTTON WOULD NOT TIGHTEN TO FIXATE TIBIA AND BECAME STUCK. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332772 ↗
• MalfunctionOct 4, 2024Failure to Advance; Failure to Advance

  ADDITIONAL INFORMATION RECEIVED ON 10/2/2024: THIS WAS DISCOVERED ON THE BACK TABLE DURING AN ACL RECONSTRUCTION WITH ALLOGRAFT AND MENISCUS REPAIR PROCEDURE. ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372450 ↗
• MalfunctionOct 4, 2024Failure to Advance; Failure to Advance

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT TWO AR-1588TN-21 TIGHTROPE II ABS SLIDING SUTURE FOR THE TIGHTROPE MECHANISM WOULDN'T SHORTEN. THE CASE WAS COMPLETED USING A THIRD AR-1588TN-21 TIGHTROPE II ABS. THE PATIENT WAS NOT AFFECTED. THE CASE WAS DELAYED FIFTEEN MINUTES IN SURGICAL TIME. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372095 ↗
• MalfunctionJun 19, 2024Use of Device Problem; Use of Device Problem

  ON 9/10/2021 IT WAS REPORTED BY SALES REP VIA EMAIL THAT AN AR-1588TN-21 TIGHTROPE® II ABS, IMPLANT OPEN COULD NOT CINCH PROPERLY AS THE CRUTCH OF THE KNOT DID NOT APPEAR AS IT SHOULD BE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. ADDITIONAL INFO RECEIVED 9/13/2021. THIS WAS DISCOVERED DURING AN ACL REPAIR. SURGEON HAD TO USED OLD TIGHTROPES TO COMPLETE CASE. FACILITY DISCARDED DEVICES THEREFORE IT WILL NOT BE RETURNING.

  Patient problems: Insufficient Information

  MAUDE report 19568487 ↗
• MalfunctionJun 17, 2024Use of Device Problem; Use of Device Problem

  ON 05/15/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588TN-21 TIGHTROPE II ABS WOULD NOT LOCK TO PRODUCE A RIDGED CONSTRUCT FOR THE TIBIAL SIDE FIXATION. THE IMPLANT HAD TO BE CUT FROM THE GRAFT AND AN ALTERNATIVE ARTHREX PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THIS WAS DISCOVERED DURING A PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19552984 ↗
• MalfunctionJun 14, 2024Use of Device Problem; Use of Device Problem

  ON 05/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THREE AR-1588TN-21 TIGHTROPE II ABS CINCHED DOWN ONTO ITSELF. THE THIRD TIGHTROPE II ABS WAS CUT AND TIED OVER THE BUTTON ON A TIGHTROPE INTERNALBRACE ALONG WITH BLUE SUTURES FROM AN ALLOGRAFT. THIS WAS DISCOVERED DURING AN ALLOGRAFT QUAD ACL PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 5/23/2024: THE CASE WAS COMPLETED USING ANOTHER AR-1588TN-21 TIGHTROPE II ABS. THE CASE WAS ONLY DELAYED BY THE AMOUNT OF TIME THAT IT TOOK TO RELOAD THE TIGHTROPE. ADDITIONAL ANESTHESIA WAS NOT NECESSARY. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19536113 ↗
• MalfunctionJun 14, 2024Use of Device Problem; Use of Device Problem

  ON 05/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THREE AR-1588TN-21 TIGHTROPE II ABS CINCHED DOWN ONTO ITSELF. THE THIRD TIGHTROPE II ABS WAS CUT AND TIED OVER THE BUTTON ON A TIGHTROPE INTERNALBRACE ALONG WITH BLUE SUTURES FROM AN ALLOGRAFT. THIS WAS DISCOVERED DURING AN ALLOGRAFT QUAD ACL PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 5/23/2024: THE CASE WAS COMPLETED USING ANOTHER AR-1588TN-21 TIGHTROPE II ABS. THE CASE WAS ONLY DELAYED BY THE AMOUNT OF TIME THAT IT TOOK TO RELOAD THE TIGHTROPE. ADDITIONAL ANESTHESIA WAS NOT NECESSARY. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19536006 ↗
• MalfunctionJun 9, 2024Break; Break

  IT WAS REPORTED ON 03/30/2023 BY A SALES REPRESENTATIVE VIA PHONE THAT 2X AR-1588TN-21 TIGHTROPE PULL TAB BROKE AND WOULD NOT PULL THROUGH TO COMPLETE THE MECHANISM. 2X BTB TIGHTROPE WAS USED TO COMPLETE PROCEDURE. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19495291 ↗
• MalfunctionJun 8, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED ON 11/15/2022 BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588TN- 21 TIGHTROPE SHUTTLING MECHANISM WOULD NOT CINCH DOWN PROPERLY. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19494177 ↗
• MalfunctionJun 7, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 05/14/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-1588TN-21 TIGHTROPE® II ABS IMPLANT HAD ONE LONG SOLID PIECE OF TAPE COME OUT. THIS OCCURRED DURING AN ACL ALLOGRAFT RECONSTRUCTION WITH FQL WHILE THE SURGEON WAS TENSIONING THE TIBIAL TIGHTROPE AND HAD GONE BACK AND FORTH WITH EACH SUTURE TAIL A FEW TIMES WHEN ONE LONG SOLID PIECE OF TAPE CAME OUT AFTER A PULL ON ONE SIDE. THE SURGEON ALWAYS WHIPSTICHES A 2ND SUTURE ON THE TIBIAL SIDE SO THEY USED THAT SAFETY STITCH TO TENSION AROUND A POST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484126 ↗
• MalfunctionJun 7, 2024Failure to Advance; Failure to Advance

  ON 11/7/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588TN-21 TIGHTROPE II ABS TAIL WOULD NOT PASS THROUGH THE LOCKING MECHANISM. THIS WAS DISCOVERED AFTER PASSING THE TIGHTROPE THROUGH THE GRAFT DURING A PCL RECONSTRUCTION PROCEDURE ON (B)(6) 2022. SURGEON COMPLETED THE CASE USING ANOTHER AR-1588TN-21 TIGHTROPE II ABS, FROM A DIFFERENT LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483894 ↗
• MalfunctionJun 6, 2024Failure to Advance; Failure to Advance

  ON 5/11/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588TN-21 TIGHTROPE II ABS SUTURE WOULD NOT SHUTTLE. ANOTHER AR-1588TN-21 TIGHTROPE II ABS WAS OPENED AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING AN ACL PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19478747 ↗
• MalfunctionJun 6, 2024Defective Device; Defective Device

  ON 05/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THREE AR-1588TN-21 TIGHTROPE II ABS CINCHED DOWN ONTO ITSELF. THE THIRD TIGHTROPE II ABS WAS CUT AND TIED OVER THE BUTTON ON A TIGHTROPE INTERNALBRACE ALONG WITH BLUE SUTURES FROM AN ALLOGRAFT. THIS WAS DISCOVERED DURING AN ALLOGRAFT QUAD ACL PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 5/23/2024: THE CASE WAS COMPLETED USING ANOTHER AR-1588TN-21 TIGHTROPE II ABS. THE CASE WAS ONLY DELAYED BY THE AMOUNT OF TIME THAT IT TOOK TO RELOAD THE TIGHTROPE. ADDITIONAL ANESTHESIA WAS NOT NECESSARY. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19476309 ↗
• MalfunctionJun 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED ON 10/25/2022 BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588TN-21 TIGHTROPE CONSTRUCT WOULD NOT SEAT. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19476102 ↗
• MalfunctionJun 4, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-1588BTB¿2J BTB TIGHTROPE WHILE PULLING THE BLUE TAB THE METAL WIRE BROKE NOT FULLY ENGAGING THE SUTURE BACK THROUGH ITSELF AND THROUGH THE BUTTON AND AN AR-1588TN-21 TIGHTROPE THE SUTURES THAT IS WRAPPED AROUND IN THE BACK OF THE CARD WAS FULLY EXTENDED AND WOULD NOT LEVEL/EVEN OUT WITH THE LOADED SUTURE. THIS OCCURRED DURING A PCL PROCEDURE CAUSE A DELAY OF ABOUT 10-15 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 19463853 ↗
• MalfunctionJun 3, 2024Failure to Advance; Failure to Advance

  ON (B)(6)2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588TN-21 TIGHTROPE II ABS WAS PASSED THROUGH THE CARD CORRECTLY, HOWEVER, IT WOULD NOT HOLD TENSION. THE IMPLANT WAS REMOVED AND AN AR-1588BTB-2J TIGHTROPE II BTB WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A AUTOGRAFT QUADLINK CONSTRUCT PROCEDURE ON (B)(6)/2022. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19447938 ↗
• MalfunctionMay 20, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED ON 08/25/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1588R-IB TIGHTROPES FLAG CAME OFF AND THE SUTURE WAS UNABLE TO PASS. AND AN AR-1588TN-21 TIGHTROPES FLAG BROKE AND THE LOOP WAS UNABLE TO BE COMPLETED. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352190 ↗
• MalfunctionMay 8, 2024Failure to Advance; Failure to Advance

  ON 10/3/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (3) AR-1588TN-21 TIGHTROPE II ABS TENSIONING SUTURES WOULD NOT TENSION AFTER ASSEMBLING. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2022. CASE WAS COMPLETED USING A BTB TIGHTROPE II ON THE TIBIAL SIDE OF THE GRAFT. ADDITIONAL INFORMATION RECEIVED ON 10/6/2022: THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION WITH GRAFTLINK AND COMPLETED WITH AN AR-1588BTB-2J TIGHTROPE II BTB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19266920 ↗
• MalfunctionMay 2, 2024Defective Device; Defective Device

  IT WAS REPORTED DURING AN ACL REPAIR THE TIGHT ROPE WOULD NOT TENSION WHEN SHUTTLING THROUGH THE SUTURE. IT WAS REMOVED AND REPLACED BUT THE SAME EVEN OCCURRED. IT WAS REPLACED WITH THE OLDER STYLE TIGHT ROPE AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. THE PATIENT IS FINE TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228291 ↗
• MalfunctionMay 1, 2024Fitting Problem; Fitting Problem

  ON 12/7/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588TN-21 TIGHTROPE II ABS MECHANISM DID NOT PULL THROUGH ITSELF TO INCORPORATE INTO THE GRAFT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19221669 ↗