Arthrex® AR-5068-45RRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867035621), received between Dec 7, 2021 and Jan 23, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Break; Material Twisted/Bent

  ON 08TH JAN 2026, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT SUTRLASSO SD SFT,45°RT CRV, R AR-5068-45R LOT 0072332 WAS BENT AND SUBSEQUENTLY BROKE DURING THE PROCEDURE PM (B)(6) 2026. THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS USING A NEW (AR-5068-XX) WITH NO FRAGMENTS RETAINED IN THE PATIENT¿S BODY AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160279 ↗
• MalfunctionDec 5, 2024Break; Break

  ON 11/06/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-5068-45R SUTURELASSO¿ SD SHAFT WERE BROKEN OFF WHILE ATTEMPTING TO PIERCE THE LABRUM. ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT AND THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A SHOULDER LABRAL REPAIR PROCEDURE (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20853397 ↗
• MalfunctionNov 27, 2024Break; Break

  ON 11/06/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06704966 THAT (QTY. 2) OF AN AR-5068-45R SUTURELASSO¿ SD SHAFT WERE BROKEN OFF WHILE ATTEMPTING TO PIERCE THE LABRUM. ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT AND THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A SHOULDER LABRAL REPAIR PROCEDURE (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800642 ↗
• MalfunctionAug 16, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-5068-45R SUTURELASSO SD SHAFT BROKE WHEN THE SURGEON USED THE DEVICE THE SECOND TIME IN THE PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY AND WITH NO PIECE BREAKING INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A MENISCUS REPAIR PROCEDURE ON (B)(6) 2023, WITH NO PATIENT HARM. ADDITIONAL INFORMATION REQUESTED ON (B)(6) 2023: THE CASE WAS COMPLETED USING A NON-ARTHREX PRODUCT WITH NO DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17559452 ↗
• MalfunctionJan 30, 2023Break

  IT WAS REPORTED ON 01/12/2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-5068-45R SUTURE LASSO NEEDLE BROKE OFF. CASE INVOLVEMENT, DEVICE BROKE DURING USE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16263830 ↗
• MalfunctionDec 7, 2021Break

  ON 9/2/2021 IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-5068-45R SUTRLASSO SD SFT,45°RT CRV,R BROKE OFF AT THE TIP. THIS WAS DISCOVERED DURING A RCR ON (B)(6) 2021. SURGEON WAS ABLE TO COMPLETE CASE BY USING A DEVICE FROM ANOTHER MANUFACTURER. NO PATIENT AFFECTED AS THE BROKEN PIECE WAS RETRIEVE FROM THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 12953782 ↗