Arthrex® AR-1588BTB-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867095366), received between Aug 8, 2023 and Sep 23, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  On 9 Sep 2026, it was reported by an Arthrex employee via email that an AR-1588BTB-J BTB TIGHTROPE W/ DEPLOYING SUTURE's lead suture snapped while attempting to pass it through the TightRope because the suture was too stiff to go through. This occurred during graft preparation for a ACLR (BTB) procedure.The procedure was completed successfully by using another AR-1588BTB-J. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867215 ↗
• MalfunctionJan 5, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT THE PULL IN SUTURE HAS TORN. 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 23960876 ↗
• MalfunctionSep 17, 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 23073116 ↗
• MalfunctionJul 9, 2025Break; Break

  ON 06/13/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT DURING A CASE INVOLVING AN AR-1588BTB-J BTB TIGHTROPE, THE IMPLANT WAS PREPARED ALONG WITH THE BONE BLOCK. AS THE BUTTON WAS ADVANCED THROUGH THE FEMORAL TUNNEL, THE SUTURE ATTACHED TO THE IMPLANT BROKE, RENDERING THE BUTTON UNUSABLE. AS A RESULT, THE SURGICAL TEAM OPTED TO CHANGE THE FIXATION METHOD. THIS WAS DISCOVERED DURING AN ACL PROCEDURE (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 06/27/2025: THE SUTURES BROKE WHILE USING A FEMORAL SUSPENSION FIXATION METHOD. DESPITE THE BREAKAGE, THE BUTTON REMAINED SECURE IN THE PATIENT, AS THE TRANSFER SUTURE WAS STILL INTACT. ALL COMPONENTS WERE REMOVED FROM THE PATIENT BEFORE PROCEEDING. TO COMPLETE THE CASE, THE SURGICAL TEAM CHANGED THE FIXATION METHOD FROM FEMORAL SUSPENSION TO FEMORAL FIXATION USING AN INTERFERENCE SCREW, AR-4030C-08. THE SURGERY WAS DELAYED BY APPROXIMATELY 30 MINUTES; HOWEVER, NO ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22455813 ↗
• MalfunctionSep 13, 2024Break; Break

  IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1588BTB-J BTB TIGHTROPE PASSING SUTURE BROKE. THERE WAS STRONG RESISTANCE WHEN PASSING ON THE CHINESE FINGER TRAP, AND THE PASSING SUTURE BROKE. THE CASE WAS COMPLETED USING ANOTHER AR-1588BTB-J BTB TIGHTROPE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON (B)(6)2024: THIS WAS DISCOVERED DURING AN ACLR PROCEDURE. THE SUTURE BROKE DURING INSERTION, AND ALL FRAGMENTS WERE REMOVED. THE CASE WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20213182 ↗
• MalfunctionJun 12, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE AR-1588BTB-J TIGHTROPE FAILED WHEN LENGTHENING LOOPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19525337 ↗
• MalfunctionJun 7, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED ON (B)(6) 2022 BY A DISTRIBUTOR VIA SEMS THAT AN AR-1588RTT TIGHTROPE IMPLANT BROKE WHILE BEING DEPLOYED AND AN AR-1588BTB-J TIGHTROPE SUTURE WAS DAMAGED AND PREVENTED THE IMPLANT TO BE USED AS INTENDED. CASE INVOLVEMENT, NO PATIENT EFFECT..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483781 ↗
• MalfunctionMay 7, 2024Component Misassembled; Component Misassembled

  ON 10/08/2021 IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1588BTB-J TIGHTROPE'S BLUE THREAD ATTACHED TO THE BUTTON WAS NOT ASSEMBLED. THIS WAS DISCOVERED AFTER OPENING. THE CASE WAS COMPLETED USING A NEW PRODUCT. THERE WAS NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION PROVIDED ON 10/11/2021. BTB ACL RECONSTRUCTION WAS BEING PERFORMED. CASE COMPLETED USING A NE AR-1588BTB-J.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19259450 ↗
• MalfunctionApr 9, 2024Fitting Problem; Fitting Problem

  ON 06/15/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1588BTB-J TIGHTROPE DID NOT SEAT CORRECTLY DURING A PROCEDURE. THE TIGHTROPE BUTTON WAS FLIPPED ONTO THE FEMORAL CORTEX AND SHORTENED AS THE BONE BLOCK ENTERED THE TUNNEL. THE TIGHTROPE THEN WOULD NOT SHORTEN ANY FURTHER CAUSING THE BUTTON TO NOT FULLY SEAT ON THE BONE. THE TIGHTROPE WAS REMOVED BY THE SURGEON CUTTING THE SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 19072842 ↗
• MalfunctionJan 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PLASTIC (SEMI-T) SURGERY THE TENSIONING SUTURE BUTTON OF THE DEVICE TORE. 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 18465613 ↗
• MalfunctionAug 24, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1588BTB-J BTB TIGHTROPE HAD AN ISSUE. THE DOCTOR FELT RESISTANCE AT THE CHINESE FINGER TRAP PART WHEN ASSEMBLING. THEY USED A NEW PRODUCT, AND THE CASE WAS COMPLETED. NO PATIENT HARM. NO CASE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17613307 ↗
• MalfunctionAug 8, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 7/11/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT THERE WAS STRONG RESISTANCE WHEN PULLING THE WIRE SNARE FROM AN AR-1588BTB-J BTB TIGHTROPE. THE CASE WAS COMPLETED USING A NEW PRODUCT. THIS WAS DISCOVERED ON THE BACK TABLE WHILE PREPPING THE GRAFT DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 7/11/2023: THE PROCEDURE PERFORMED WAS AN ACL REPAIR. THE CASE WAS COMPLETED BY USING A NEW AR-1588BTB-J.

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

  MAUDE report 17479649 ↗