Arthrex® AR-1588RTSRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867019607), received between Oct 31, 2019 and Jan 22, 2026 — classified as 1 injury, 7 malfunctions.

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

• MalfunctionJan 22, 2026Break

  ON 09-JAN-2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1588RTS ACL TIGHTROPE RT SUTURE BROKE. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147472 ↗
• MalfunctionDec 8, 2025Break; Break

  ON 11/19/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1588RTS ACL TIGHTROPE® RT IMPLANT DELIVERY SYSTEM HAD AN IMPLANT SUTURE THAT WAS DAMAGED AND BROKE WHEN THE GRAFT WAS LIFTED. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744061 ↗
• MalfunctionJun 27, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE SUTURE BROKE WHILE TIGHTENING THE LOOP. 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 19624400 ↗
• MalfunctionJun 14, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGERY THE TIGHTROPE TORE WHILE TIGHTENING. 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 19542771 ↗
• MalfunctionMay 20, 2024Defective Device; Defective Device

  ON 11/22/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN ACL TIGHTROPE RT IMPLANT DELIVERY SYSTEM FAILED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 19354001 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT DURING ACL SURGERY THE THREAD IS BROKEN. THE DEVICE BROKE OFF BEFORE IT WAS INSERTED INTO THE PATIENT¿S BODY. THERE WAS NO HARM OR ADVERSE EVENT 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. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19130929 ↗
• MalfunctionOct 10, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE TIGHTROPE TORE WHILE THE SURGEON PULLED IN THE CRUCIATE LIGAMENT. 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: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908530 ↗
• InjuryOct 31, 2019Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PRIMARY ACL RECONSTRUCTION WITH A SEMI ALLOGRAFT ON (B)(6) 2019. THE PATIENT RETURNED FOR POST OP FOLLOW UP IN THE SURGEON'S OFFICE AND X-RAYS FOUND THAT THE CORTICAL RT BUTTON APPEARED TO BE WITHIN THE FEMORAL CANAL. CLINICALLY THE PATIENT WAS FELT TO HAVE A POSITIVE LACHMAN, ALTHOUGH THEY WERE NOT SYMPTOMATIC. ON (B)(6) 2019, THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM; THE TAILS OF THE TIGHTROPE WERE FOUND THROUGH A LATERAL INCISION AND FIXED PROXIMALLY WITH A 4.75 SWIVELOCK TO RE-TENSION THE GRAFT. A 3.5 SWIVELOCK WAS PLACED IN THE 4MM CORTICAL EXIT HOLE AND THE TIGHTROPE AND BUTTON WERE LEFT IN PLACE. THE SURGEON WAS HAPPY WITH GRAFT TENSION AND FELT THE LACHMAN WAS NOW NEGATIVE. ADDITIONAL INFORMATION PROVIDED 10/31/2019: THERE WERE NO DEVICES REMOVED FROM THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 9261234 ↗