Arthrex® AR-1588HRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867019546), received between Jul 14, 2023 and Sep 30, 2026 — classified as 3 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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 30, 2026Fracture

  It was reported that during a surgery the device showed signs of wear and tear. The customer reports that they are requesting a replacement of the instrument due to wear and tear over time. Per complaint reporter there was no harm for patient, operator or third party. No further information received.***Update 17-Sep-2026It was further reported that the event occurred during the surgical procedure. While using the instruments, the surgeon applied slightly increased force to tension the tensioning devices. As a result, the tensioning device fractured and a portion of a suture remained inside the patient; however, it was successfully retrieved without complications. 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 50945083 ↗
• MalfunctionJan 31, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 1/9/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-1588H TIGHTROPE SUTURE TENSIONER HAD A SUTURE STUCK IN THE HANDLE AND COULD NOT BE REMOVED. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 1/24/2024: THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION ON (B)(6) 2024. THE CASE WAS COMPLETED USING ANOTHER AR-1588H TIGHTROPE SUTURE TENSIONER. THERE WAS NO ADVERSE EFFECTS ON THE PATIENT DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614229 ↗
• MalfunctionJul 14, 2023Break; Break

  ON (B)(6) 2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1588H TIGHTROPE® SUTURE TENSIONER BROKE. THIS OCCURRED DURING A CASE WHEN TIGHTENING THEY BROKE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED ON 06/26/2023, IT WAS REPORTED THAT THIS EVENT OCCURRED DURING AN ACL RECONSTRUCTION ON (B)(6) 2023 . ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17329719 ↗