Arthrex® AR-1588BTBRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00888867019515), received between Jun 14, 2018 and Mar 23, 2026 — classified as 5 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE TORE. 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 24661673 ↗
• MalfunctionOct 15, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE BLUE SUTURE DID NOT PASS THROUGH THE WHITE SUTURE, SO THE DEVICE DID NOT 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 23294211 ↗
• MalfunctionSep 3, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1588BTB, BTB TIGHTROPE®, AFTER AR-1588RT-IB BROKE (CASE-(B)(4)), AR-1588BTB WAS OPENED TO BE USED AS A NEW FEMORAL TIGHTROPE. WHEN CINCHING THE GRAFT INTO THE FEMORAL SOCKET, THE BTB TIGHTROPE BROKE. IT WAS ALSO REPORTED THAT FOR AN AR-2324PSLC, SUTURE ANCHOR, PEEK-SWIVELOCK® C, 4.75 X 19.1 MM, VENTED, WHEN ATTEMPTING TO SECURE THE INTERNAL BRACE TO THE SHIN, THE ANCHOR THREADS BROKE/BENT UPON INSERTION. THE DOCTOR DRILLED 4.5MM INTO THE MEDIAL TIBIA AND USED 4.75 SWIVELOCK TAP. THIS WAS DETECTED DURING USE IN A ACL GRAFTLINK PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A 2ND AR-1588RT-IB TIGHTROPE WAS OPENED AND USED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 22950923 ↗
• MalfunctionJul 9, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE AR-1588T (LOT: 15378964) BLOCKED WHEN PULLING IN AND SHORTENING. TENSION CORDS ULTIMATELY TORE DURING FURTHER RETRACTION. THE TIGHTROPE IMPLANT WAS COMPLETELY REMOVED FROM THE KNEE JOINT AND CUT OFF FROM THE GRAFT. THE SURGEON WANTED TO USE A BTB TIGHTROPE, BUT THE DEVICE COULD NOT BE THREADED DURING USE AS PER INSTRUCTIONS. THE DEVICE AR-1588BTB (LOT: 14200696) COULD THEREFORE NOT BE USED. THE GRAFT WAS THEN FIXED FEMORALLY WITH A RESORBABLE SCREW. 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 22456052 ↗
• MalfunctionOct 8, 2024Break; Break

  ON 11/21/2024 ADDITIONAL INFORMATION WAS RECEIVED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL WHO STATED THAT THE PROCEDURE PERFORMED WAS AN ACL WITH PATELLAR GRAFT. WHILE PULLING THE BLUE WIRE TO TRANSPORT THE WHITE WIRE THE BLUE WIRE BROKE. A NEW BTB IMPLANT WAS OPENED TO COMPLETE THE CASE. THERE WAS NO DELAYS OR NEED FOR ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 20397271 ↗
• MalfunctionSep 12, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  A SALES REPRESENTATIVE REPORTED THAT AN AR-1588BTB BTB TIGHTROPE OUTER SHEATH BUNCHED UP AROUND THE BOTTOM, CAUSING ELASTICITY IN THE TIGHTROPE. ANOTHER DEVICE WAS SWAPPED TO COMPLETE THE CASE WITHOUT ADVERSE EFFECTS ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2024: THIS OCCURRED AFTER SHUTTLING THROUGH THE TUNNEL AND TRYING TO TIGHTEN THE GRAFT DOWN. ANOTHER NEW AR-1588BTB WAS OPENED TO COMPLETE THE CASE. THE ENTIRE IMPLANT WAS REMOVED FROM PATIENT AND THEN CUT OFF BONE BLOCK. THERE WAS A 8-10 MINUTE DELAY INCLUDING PUTTING THE NEW IMPLANT ON THE BONE BLOCK. THIS WAS DISCOVERED DURING A BTB ACL PROCEDURE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20201067 ↗
• MalfunctionJul 22, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY THE DEVICE WITH THE PART NUMBER AR-1588BTB COULD NOT BE THREADED. 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. **UPDATED CASE (B)(4). IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY THE DEVICE WITH THE PART NUMBER AR-1588BTB COULD NOT BE THREADED. WHEN USING THE PRODUCT, IT COULD NOT BE THREADED IN AS PER THE INSTRUCTIONS. THE THREAD BROKE AND THE IMPLANT WAS NO LONGER USABLE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A RESORBABLE SCREW FIXING THE GRAFT FEMORALLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19802154 ↗
• MalfunctionJun 27, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE THREAD IS BROKEN WHEN PULLING THROUGH. THE LOOP COULD NOT BE PRODUCED. 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 19624487 ↗
• MalfunctionJun 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE THREAD TORE. 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, (B)(4), 19-APR-2023 FURTHER INFORMATION RECEIVED WITH THE DEVICE. ACCORDING TO THE SURGEON, THE TRACTION THREAD WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19498679 ↗
• MalfunctionJun 7, 2024Use of Device Problem; Use of Device Problem

  ON 1/11/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT QUANTITY 2 OF AN AR-1588BTB BTB TIGHTROPE OVER TENSIONED ON ITSELF DURING PASSING AND WOULD NOT LOOSEN. THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A ACL RECONSTRUCTION ON (B)(6) 2023 WITH NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION RECEIVED ON 01/11/2023: THE CASE WAS COMPLETED WITH AN AR-1588BTB-IB TIGHTROPE. NO PHOTOS WERE TAKEN FOR THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19488279 ↗
• MalfunctionJun 7, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE WIRE OF THE SECOND IMPLANT (AR-1588BTB, LOT 11883419) TORE INSIDE THE PATIENT WHEN THE SURGEON PULLED THE WIRE FROM THE ANCHOR AFTER HE PUT THE SCREW. IT WAS FURTHER REPORTED THAT THERE WAS NO IMPLANT TO RECOVER. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE ACL SURGERY WAS FINISHED SUCCESSFULLY AND THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE (B)(4) 2021: IT WAS CONFIRMED THAT THE SECOND IMPLANT WAS DEPLOYED SUCCESSFULLY, ALTHOUGH THE WIRE TORE. NOTHING HAD TO BE RETRIEVED FROM THE PATIENT. THEY WERE ABLE TO FIX THE IMPLANT AS SPECIFIED IN THE DFU DESPITE THE TORN WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19486251 ↗
• MalfunctionJun 7, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SURGERY THE SUTURES RUPTURED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. 6-FEB-2023 UPDATE DW. FURTHER INFORMATION WERE PROVIDED THAT THE REPORTED EVENT OCCURRED DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY. 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 19482503 ↗
• MalfunctionJun 6, 2024Unintended Movement; Unintended Movement

  ON 1/10/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT (2) AR-1588BTB BTB TIGHTROPE LOCKING MECHANISM FAILED. THIS WAS DISCOVERED DURING A PCL PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 1/10/2023: BOTH INSTANCES OF USE WITH A GRAFTLINK, WHEN PASSING THE SUTURE LIMB THROUGH THE TIGHTROPE TO FINALIZE THE CONSTRUCT, WHEN PULLED, THE LOCKING MECHANISM SLIPPED UNDER THE BUTTON, AND SURGEON COULDN'T GET IT BACK TO SET THE WAY IT SHOULD. CASE WAS COMPLETED WITH AN AR-1588TN-1 TIGHTROPE ABS.

  Patient problems: Insufficient Information

  MAUDE report 19476699 ↗
• MalfunctionJun 3, 2024Break; Break

  ON (B)(6) 2021 , IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT WHILE USING AN AR-1588BTB TIGHTROPE, THE SUTURE BROKE WHILE TRYING TO PASS THE GRAFT. THIS WAS DISCOVERED DURING USE IN A PROCEDURE ON (B)(6) 2021. THE CASE WAS COMPLETED WITH A NEW AR-1588BTB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446900 ↗
• MalfunctionMay 20, 2024Unintended Movement; Unintended Movement

  ON 1/10/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT (2) AR-1588BTB BTB TIGHTROPE LOCKING MECHANISM FAILED. THIS WAS DISCOVERED DURING A PCL PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 1/10/2023: BOTH INSTANCES OF USE WITH A GRAFTLINK, WHEN PASSING THE SUTURE LIMB THROUGH THE TIGHTROPE TO FINALIZE THE CONSTRUCT, WHEN PULLED, THE LOCKING MECHANISM SLIPPED UNDER THE BUTTON, AND SURGEON COULDN'T GET IT BACK TO SET THE WAY IT SHOULD. CASE WAS COMPLETED WITH AN AR-1588TN-1 TIGHTROPE ABS.

  Patient problems: Insufficient Information

  MAUDE report 19352307 ↗
• MalfunctionApr 2, 2024Failure to Advance; Failure to Advance

  ON 02/09/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A AR-1588BTB BTB TIGHTROPE® WOULD NOT DEPLOY CORRECTLY, THE SHUTTLE SUTURE CAME UNTIED.

  Patient problems: Insufficient Information

  MAUDE report 19021442 ↗
• MalfunctionMar 29, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY, WITH BTB TECHNIQUE, THE BLUE PULL THROUGH SUTURE WAS STUCK; THEREFORE, THE WHOLE DEVICE COULD NOT BE PULLED THROUGH. ACCORDING TO THE SURGEON 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 19008507 ↗
• MalfunctionMar 29, 2024Defective Device; Defective Device

  IT WAS REPORTED ON 09/15/2022 BY A DISTRIBUTOR VIA EMAIL THAT AN AR-1588BTB TIGHTROPE MECHANISM WOULD NOT ENGAGE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19006243 ↗
• MalfunctionFeb 5, 2024Material Rupture; Material Rupture

  ON 1/15/2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT WHEN THE BTB TIGHTROPE, AR-1588BTB, GRAFT WAS GOING UP, ONE OF THE SEMITENDINOSUS SUTURES BURST AND ONLY THE GRACIL WENT UP. SURGEON MANAGED TO GET THE BUTTON DOWN, BUT IT HAD ALREADY CLOSED THE CHINESE MESH, MAKING IT IMPOSSIBLE TO USE IT TO FINISH THE PROCEDURE. ANOTHER TIGHTROPE WAS USED AND THE CASE WAS COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641499 ↗
• MalfunctionJan 12, 2024Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE TIGHTENING SUTURE WAS TORN OFF WHILE IT WAS TIGHTENED. 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 18502485 ↗
• MalfunctionJan 11, 2024Break; Break

  ON 11/30/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588BTB BTB TIGHTROPE SUTURE BROKE DURING TENSIONING. THIS WAS DISCOVERED DURING AN ACRL PROCEDURE ON (B)(6) 2022. CASE WAS COMPLETED BY REMOVING ALL BROKEN FRAGMENTS AND USING ANOTHER AR-1588BTB BTB TIGHTROPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18492813 ↗
• MalfunctionOct 23, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE COULD NOT BE TIGHTENED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17985796 ↗
• MalfunctionSep 1, 2023Defective Device; Material Split, Cut or Torn; Defective Device; Material Split, Cut or Torn

  THERE WAS REPORTED THAT DURING A CRUCIATE LIGAMENT AND PATELLA SURGERY THE BLUE SUTURE TORE. 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: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671377 ↗
• MalfunctionAug 2, 2023Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance

  ON (B)(6)/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT A BTB TIGHTROPE CHINESE MESH GOT STUCK AND WOULD NOT ADVANCE. THE SURGEON COULD NOT UNLOCK THE MESH, AND THE BUTTON FAILED TO RISE. THE CASE WAS COMPLETED USING ANOTHER TIGHTROPE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6)2023. ADDITIONAL INFORMATION REQUESTED.

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

  MAUDE report 17441654 ↗
• InjuryMay 3, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1588BTB BTB TIGHTROPE BROKE THE WIRE DURING THE PROCEDURE. THE SURGEON SWITCHED TECHNIQUES TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE ON 4/7/2023. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860479 ↗