Arthrex® AR-1588TB-5Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867240582), received between Dec 27, 2021 and Nov 21, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Break; Break

  ON 11/03/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1588TNT2 FIBERTAG® TIGHTROPE® II ABS IMPLANT, AND AN AR-1588TB-5 TIGHTROPE® ABS BUTTON BROKE. THIS OCCURRED DURING A QUAD TENDON ACL RECONSTRUCTION ON (B)(6) 2025. WHEN THE SURGEON BEGAN TENSIONING THE AR-1588TNT2 BROKE RESULTING IN THE AR-1588TB-5 BUTTON BREAKING AND FALLING OUT TO THE FLOOR. ALL FRAGMENTS WERE RECOVERED FROM THE PATIENT. THE PATIENT HAD A GOOD BONE QUALITY, AND IT WAS UNCERTAIN IF ANYTHING WAS USED TO PREPARE THE BONE. THERE WAS A DELAY OF ABOUT 30 MINUTES THAT REQUIRED ADDITIONAL ANESTHESIA FOR THAT TIME. THE PROCEDURE WAS COMPLETED USING ANOTHER AR-1588TNT2 FIBERTAG® TIGHTROPE® II ABS IMPLANT, AND ANOTHER AR-1588TB-5 TIGHTROPE® ABS BUTTON. THERE WAS NO HARM ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618572 ↗
• MalfunctionDec 27, 2021Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY WHEN THE SURGEON STRETCHED THE IMPLANT AR-1588RTT DURING THE SURGERY AS A TECHNIQUE, WITHOUT APPLYING ADDITIONAL FORCE THE IMPLANT AR-1588RTT BROKE AND THE SURGERY WITH THIS IMPLANT COULD NO LONGER BE CONTINUED. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE FROM A DIFFERENT MANUFACTURER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. BECAUSE THE IMPLANT WAS IN CONTACT WITH THE PATIENT, IT WAS DISCARDED DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087760 ↗