Arthrex® AR-1588RT-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867319707), received between Aug 25, 2023 and Aug 12, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025Break; Break

  ON 07/25/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-1588RT-2 TIGHTROPE WHEN TENSIONING, THE INTERLINKING BUTTON FIBER ROPE BROKE. THIS ISSUE OCCURRED DURING CASE THE PATIENT NOT AFFECTED HOWEVER THE WAS CONCERN BECAUSE THE PATIENT WAS UNDER ANESTHESIA LONGER THAN NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22787309 ↗
• MalfunctionJan 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE DEVICE 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 SWIT 07-MAR-2023: THE DEVICE TORE INSIDE PATIENT, BUT ALL PARTS WERE RETRIEVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18542197 ↗
• InjuryAug 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2023, IT WAS REPORTED BY A PATIENT VIA PHONE THAT A CMC TIGHTROPE SYSTEM HAD FAILED AFTER ADDITIONAL SURGERY, THE PART AND LOT NUMBER WERE UNKNOWN. THE PATIENT HAD AN INITIAL BASAL ARTHROSCOPY AND TENDON TRANSFER PROCEDURE IN THE LEFT THUMB ON (B)(6), 2021. NO ARTHREX PRODUCTS WERE USED IN THE INITIAL PROCEDURE DUE TO HER KNOWLEDGE. THE PATIENT STATED SHORTLY AFTER THE PROCEDURE, IT DID NOT FEEL RIGHT. MRIS WERE TAKEN, AND A DYNAMIC STUDY OF THE HAND WAS MADE, AND IT WAS DISCOVERED THAT THE TENDON WAS GONE, AND THERE WAS A CRUNCHING NOISE HEARD. UPON SEEING A DIFFERENT SURGEON, IT WAS CONFIRMED THAT THE TENDON HAD DETACHED AFTERWARD. ON (B)(6) 2023, AN ADDITIONAL SURGERY WITH THE ARTHREX CMC TIGHTROPE WAS PERFORMED. ON (B)(6), 2023, AN X-RAY WAS TAKEN, AND THE TIGHTROPE BUTTONS WERE THERE, BUT THE BONE WAS DROPPED. AN MRI WILL BE SCHEDULED SOON TO VERIFY THE LOCATION OF THE BRAIDED POLYESTER. SHE ASKED ABOUT FAILURE MODES FOR THIS TYPE OF SURGERY AND THE CMC TIGHTROPE SYSTEM AND STATED THAT THIS WAS NOT A COMPLAINT, BUT HER BODY SEEMED TO HAVE REJECTED THE DEVICE. SHE SAID SHE WAS NOT TRYING TO SUE OR BLAME ANYONE, BUT SHE WAS WORRIED THAT IT MIGHT BE HER BODY, SHE ALSO H

  Patient problems: Joint Dislocation

  MAUDE report 17626435 ↗