Arthrex® AR-1588TB-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867157736), received between Sep 8, 2025 and Mar 3, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY DURING THE PASSAGE OF THE GRAFT INTO THE FEMORAL CANAL, THE SUTURE FROM THE TIGHTROPE II RT IMPLANT AR-1588RT-2J TORE. IT WAS NECESSARY TO RE-SUTURE THE GRAFT AND USE OTHER IMPLANTS (INCLUDING THOSE IN THE TIBIAL CANAL). EVERYTHING WAS PERFORMED ACCORDING TO THE TECHNIQUE. 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. UPDATE 17-FEB-2026. IT WAS FURTHER REPORTED THAT ALL THREE DEVICES TORE AND WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496199 ↗
• MalfunctionDec 16, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING THE ANTERIOR CRUCIATE LIGAMENT SURGERY, THE BUTTON OF THE TIGHTROPE MALFUNCTIONED. 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 23818559 ↗
• MalfunctionDec 9, 2025Positioning Failure; Use of Device Problem; Positioning Failure; Use of Device Problem

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1588TB-4 ROUND, CONCAVE, Ø 14 MM TIGHTROPE ABS BUTTON COULD NOT BE SECURED TO THE CORTEX WHEN REINSERTING DUE TO THE PATIENT'S CONDITION. A FLAT BUTTON WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757687 ↗
• MalfunctionSep 8, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURES OF THE DEVICE TORE DURING IMPLANT 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 22997442 ↗