Arthrex® AR-1588R-IBRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00888867363656), received between Aug 15, 2023 and Jul 29, 2026 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50070547 ↗
• MalfunctionFeb 17, 2026Failure to Advance

  ON 29TH JANUARY 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1588R-IB, ACL REPAIR TIGHTROPE®, WITH INTERNALBRACE¿ LIGAMENT AUGMENTATION, THE ACL REPAIR TIGHTROPE TAB (STEP 3) FAILED TO PULL THROUGH BUTTON - NITINOL WOULD NOT ADVANCE THROUGH TIGHTROPE BUTTON SO THE SURGEON HAD TO CUT IT OFF. THIS WAS DETECTED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2026. (REQUESTING FURTHER INFORMATION FROM COMPLAINT INITIATOR).

  Patient problems: Insufficient Information

  MAUDE report 24363602 ↗
• MalfunctionOct 15, 2025Break; Break

  ON 10/02/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE BLUE FLAG WITH THE NITINOL WIRE ON AN AR-1588R-IB ACL REPAIR TIGHTROPE HAD BROKEN. ANOTHER AR-1588R-IB ACL REPAIR TIGHTROPE WAS OPENED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN ACL REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 10/10/2025: THE ISSUE OCCURRED DURING USE WHEN THE BLUE FLAG WITH THE NITINOL WIRE BROKE WHILE PASSING THE SUTURE THROUGH IT. NO FRAGMENTS WERE LEFT IN THE PATIENT. THE SURGERY EXPERIENCED A BRIEF DELAY OF A FEW MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292672 ↗
• MalfunctionSep 15, 2025Material Frayed; Mechanical Jam; Material Frayed; Mechanical Jam

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1588R-IB ACL REPAIR TIGHTROPE, WITH INTERNALBRACE LIGAMENT AUGMENTATION, EXPERIENCED AN ISSUE DURING USE. SPECIFICALLY, THE TIGHTROPE MECHANISM FAILED TO CINCH PROPERLY, AND THE SUTURES BECAME FRAYED. THE FRAYED SUTURES WERE REMOVED, AND THE REPAIR WAS COMPLETED BY MANUALLY TYING THE TIGHTROPE USING THE KNOTLESS MECHANISM. NO ADDITIONAL PRODUCTS WERE USED TO COMPLETE THE CASE. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 20 MINUTES, WITH NO ADDITIONAL ANESTHESIA ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED, AND NO PHOTOGRAPHS WERE TAKEN. THIS ISSUE WAS IDENTIFIED DURING AN ACL REPAIR PROCEDURE PERFORMED ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057350 ↗
• MalfunctionAug 20, 2025Use of Device Problem; Use of Device Problem

  ON 08/05/2025, A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588R-IB ACL REPAIR TIGHTROPE WOULD NOT CONVERT. THIS OCCURRED DURING AN ACL REPAIR ON (B)(6) 2025. THE PATIENT HAD FINE BONE QUALITY. ALL PORTIONS OF THE DEVICE WERE RECOVERED FROM THE PATIENT. THE CASE WAS COMPLETED USING ANOTHER AR-1588R-IB ACL REPAIR TIGHTROPE.

  Patient problems: Insufficient Information

  MAUDE report 22851840 ↗
• MalfunctionJul 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 10TH JULY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1588R-IB, ACL REPAIR TIGHTROPE®, WITH INTERNALBRACE¿ LIGAMENT AUGMENTATION, AS THE SURGEON WAS PERFORMING AN ACL REPAIR, ON FINAL TENSIONING OF THE ACL REPAIR TIGHTROPE, ONE OF THE TIGHTROPE TAILS SNAPPED BELOW THE BUTTON. IT WAS ALSO REPORTED THAT 2 UNITS OF AR-2923BC-1, SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK®, SL 2.9 MM X 12.5 MM, SEQUENTIALLY PULLED OUT AFTER INSERTION. THIS WAS DETECTED DURING USE IN AN ACL REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE SURGEON LOADED THE REMAINING TIGHTROPE TAIL INTO A 2.9 PUSHLOCK FOR INSERTION INTO THE FEMUR FOR EXTRA FIXATION AND THE SURGEON RESORTED TO USING A 3.5MM SWIVELOCK FOR THE 2 AR-2923BC-1 THAT WERE PULLED OUT.

  Patient problems: Insufficient Information

  MAUDE report 22639651 ↗
• MalfunctionJun 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ASK KNEE SURGERY THE TIGHTROPE RIPPED OFF 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 22134621 ↗
• MalfunctionMay 28, 2025Break; Break

  ON 05/02/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT (QTY. 2) OF AN AR-1588R-IB ACL REPAIR TIGHTROPE EXPERIENCED SUTURE FAILURE WITHIN THE LOCKING MECHANISM, SPECIFICALLY THROUGH THE BUTTON, BEFORE THE ACL GRAFT WAS FULLY TENSIONED. THE SUTURE BROKE INSIDE THE PATIENT, BECAME SHREDDED, AND WAS SUCCESSFULLY RETRIEVED. BOTH DEVICES BELONGED TO THE SAME LOT NUMBER AND FAILED AT THE EXACT LOCATION. SINCE ONLY TWO ACL REPAIR TIGHTROPES WERE AVAILABLE, THE PROCEDURE WAS COMPLETED USING A BTB TIGHTROPE. THIS WAS DISCOVERED DURING AN ACL REPAIR 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 22095288 ↗
• MalfunctionMay 28, 2025Break; Break

  ON 05/02/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT (QTY. 2) OF AN AR-1588R-IB ACL REPAIR TIGHTROPE EXPERIENCED SUTURE FAILURE WITHIN THE LOCKING MECHANISM, SPECIFICALLY THROUGH THE BUTTON, BEFORE THE ACL GRAFT WAS FULLY TENSIONED. THE SUTURE BROKE INSIDE THE PATIENT, BECAME SHREDDED, AND WAS SUCCESSFULLY RETRIEVED. BOTH DEVICES BELONGED TO THE SAME LOT NUMBER AND FAILED AT THE EXACT LOCATION. SINCE ONLY TWO ACL REPAIR TIGHTROPES WERE AVAILABLE, THE PROCEDURE WAS COMPLETED USING A BTB TIGHTROPE. THIS WAS DISCOVERED DURING AN ACL REPAIR 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 22095252 ↗
• MalfunctionMay 2, 2025Material Split, Cut or Torn; Material 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 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 21949654 ↗
• MalfunctionApr 3, 2025Break; Break

  ON 3/11/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE BLACK AND WHITE TIGHTROPE PASSING SUTURE FROM AN AR-1588R-IB ACL REPAIR TIGHTROPE WITH INTERNALBRACE STRIPPED AND BROKE IN HALF WHEN PASSED THROUGH THE FIBERRING. A NEW TIGHTROPE WAS NEEDED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN ACL REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION RECEIVED ON 3/18/2025: THE AR-1588R-IB ACL REPAIR TIGHTROPE WITH INTERNALBRACE WAS COMPLETELY REMOVED FROM THE PATIENT A NEW ONE WAS USED TO COMPLETE THE CASE. THE CASE WAS NOT DELAYED.

  Patient problems: Insufficient Information

  MAUDE report 21761865 ↗
• MalfunctionApr 2, 2025Break; Use of Device Problem; Break; Use of Device Problem

  ON 3/14/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588R-IB ACL REPAIR TIGHTROPE WITH INTERNALBRACE MECHANISM DID NOT CONVERT. THE SUTURE DID NOT GO THROUGH THE BUTTON AND THE CONVERTING FLAG BROKE. THIS OCCURRED OUTSIDE OF THE PATIENT'S KNEE DURING AN ACL REPAIR PROCEDURE ON (B)(6) 2025. THE CASE WAS COMPLETED USING A BTB TIGHTROPE. THE CASE WAS NOT DELAYED AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21755700 ↗
• MalfunctionMar 19, 2025Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED ON 03/10/2025: THIS ISSUE OCCURRED WHILE PASSING IT THROUGH THE FIBERRINGS INSIDE OF THE PATIENT. ANOTHER AR-1588R-IB WAS USED TO COMPLETE THE CASE. THE CASE WAS DELAYED FOR 30 MINUTES, AND AN UNKNOWN AMOUNT OF EXTRA ANESTHESIA WAS ADMINISTERED DUE TO THE DELAY.

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

  MAUDE report 21641511 ↗
• 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 20781847 ↗
• MalfunctionJul 3, 2024Use of Device Problem; Use of Device Problem

  ON 06/5/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588R-IB ACL REPAIR TIGHTROPE WITH INTERNALBRACE THE LEADER SUTURE, WITHOUT VISUAL NOTICE, WAS KNOTTED ON ITSELF AROUND THE FIBERRINGS. THE KNOT WAS UNABLE TO BE UNTIED VIA ARTHROSCOPIC TECHNIQUE AND THE SURGEON ELECTED TO CUT THE TIGHTROPE OUT OF THE CONSTRUCT. THE FIBERRING SUTURES STAYED IN PLACE. THIS WAS DISCOVERED DURING AN ACL TIBIAL AVULSION REPAIR PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 6/11/2024: THIS OCCURRED DURING INSERTION. THE CASE WAS DELAYED ABOUT TEN MINUTES; HOWEVER, THE SALES REPRESENTATIVE IS UNSURE IF ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 19667921 ↗
• InjuryJun 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 01 MAY 2024 IT WAS REPORTED BY A PRODUCT SURVEILLANCE SPECIALIST IN ARTHREX INC THAT THEY HAD RECEIVED A REPORT OF A POTENTIAL ADVERSE EVENT THAT OCCURRED DURING A CLINICAL STUDY IN THE UNIVERSITY OF WESTERN AUSTRALIA. THE ARTHREX PRODUCTS THAT WERE INVOLVED WERE: AR-1588R-IB ACL REPAIR TIGHTROPE, WITH INTERNALBRACE, AR-2324PSLC-1 PEEK SWIVELOCK C,4.75X19.1MM & AR-7282-25-1 FIBERRING WITH SHUTTLE SUTURE25MM,SINGLE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED POST-OPERATIVE PARTIAL OCCLUSION OF PERONEAL VEIN, TREATED WITH ELIQUIS WITH FULL RECOVERY AND WITHOUT FURTHER SEQUALAE. MORE INFORMATION TO BE CONFIRMED. THERE WAS CASE INVOLVEMENT.

  Patient problems: Failure of Implant

  MAUDE report 19562862 ↗
• MalfunctionJun 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 01 MAY 2024 IT WAS REPORTED BY A PRODUCT SURVEILLANCE SPECIALIST IN ARTHREX INC THAT THEY HAD RECEIVED A REPORT OF A POTENTIAL ADVERSE EVENT THAT OCCURRED DURING A CLINICAL STUDY IN THE (B)(6). THE ARTHREX PRODUCTS THAT WERE INVOLVED WERE: AR-1588R-IB ACL REPAIR TIGHTROPE, WITH INTERNALBRACE, AR-2324PSLC-1 PEEK SWIVELOCK C,4.75X19.1MM & AR-7282-25-1 FIBERRING WITH SHUTTLE SUTURE25MM,SINGLE. IT WAS REPORTED THAT THE PATIENT THAT UNDERWENT AN ACL REPAIR HAS HAD A LATERAL EXTRA-ARTICULAR TENODESIS ON THE SAME LEG AT 8 MONTHS POST- ACL REPAIR SURGERY. THERE WAS CASE INVOLVEMENT.

  Patient problems: Failure of Implant

  MAUDE report 19480438 ↗
• MalfunctionMay 22, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SUTURING OF THE MENISCUS AND AN ACL REPAIR SURGERY THE SUTURE BROKE WHILE TIGHTENING THE LOOP (AR-1588R-IB). 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 19377550 ↗
• 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 19350566 ↗
• MalfunctionApr 15, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE WHITE SUTURE OF THE DEVICE COULD NOT BE LOADED INTO THE LOOP TRAP. 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. UPDATE AVOE 02-APR-2024 IT WAS CONFIRMED THAT WHEN LOADING THE LOOP SYSTEM WITH THE WIRE LOOP, THE WIRE LOOP BROKE. UPDATE AVOE 04-APR-2024 THE FAILURE OCCURRED OUTSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19110721 ↗
• MalfunctionApr 2, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE DID NOT DRAG. 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. UPDATE AVOE 22-DEC-2022 FURTHER INFORMATION WAS PROVIDED ABOUT THE FAILURE AND IT WAS CONFIRMED THAT THE LIGAMENT COULDN'T BE PULLED UP TO THE THIGH (WAS NOT SUBMITTED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021102 ↗
• MalfunctionJan 24, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY THE WHITE SUTURE COULD NOT BE PULLED INTO THE TIGHTROPE MECHANISM. 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 18574430 ↗
• MalfunctionJan 24, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY THE WHITE SUTURE COULD NOT BE PULLED INTO THE TIGHTROPE MECHANISM. 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 18571804 ↗
• MalfunctionJan 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SUTURE SURGERY THE WHITE SUTURE OF THE DEVICE TORE WHICH RESULTED IN AN UNSTABLE RECONSTRUCTION. DUE TO THE FAILURE, THE TWO FIBERRINGS AR-7282-25-1 COULD NOT BE USED AND HAD TO BE RETRIEVED OUT OF THE PATIENT AS WELL. 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 18464735 ↗
• MalfunctionJan 4, 2024Break; Break

  ON 9/27/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588R-IB ACL REPAIR TIGHTROPE WITH INTERNALBRACE LEADER STITCH BROKE OFF OF THE DEVICE. THIS WAS DISCOVERED DURING A PROCEDURE ON 9/26/2022. ADDITIONAL INFORMATION RECEIVED ON 9/27/2022: THIS WAS DISCOVERED DURING AN ACL REPAIR ON 9/26/2022. ALL BROKEN PIECES WERE REMOVED AND CASE WAS COMPLETED WITH ANOTHER AR-1588R-IB ACL REPAIR TIGHTROPE.

  Patient problems: Insufficient Information

  MAUDE report 18446551 ↗