Arthrex® AR-6065-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867288652), received between Mar 2, 2021 and Feb 27, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT DURING A SURGERY, THE NITENOL LOOP TORE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION WAS RECEIVED. UPDATE 19-FEB-2026 - FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT DURING THE LABRUM REFIXATION, THE NITENOL LOOP TORE. 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 24474577 ↗
• MalfunctionJan 12, 2026Use of Device Problem

  ON 23-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-6065-90 ROTATION LASSO, 90° EXPERIENCED AN ISSUE DURING A PROCEDURE ON(B)(6) 2025. THE WHITE KNOB DID NOT ROTATE AS INTENDED WHILE THE DEVICE WAS IN USE INSIDE THE PATIENT. ALL COMPONENTS WERE SUCCESSFULLY REMOVED, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE PRODUCT WITHOUT DELAY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24039348 ↗
• MalfunctionDec 18, 2025Break; Break

  ON 11/28/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6065-90 ROTATION LASSO NITINOL LOOP FROM THE DEVICE BROKE WHILE TRYING TO RETRIEVE THE SUTURE FROM AROUND THE LABRUM. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23837497 ↗
• MalfunctionSep 11, 2025Break; Break

  ON 08/22/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. (B)(4) OF AN AR-6065-90 ROTATION LASSO WIRES BROKE WHEN TRYING TO PULL SUTURE OUT OF THE JOINT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23030464 ↗
• MalfunctionSep 11, 2025Break; Break

  ON 08/22/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-6065-90 ROTATION LASSO WIRES BROKE WHEN TRYING TO PULL SUTURE OUT OF THE JOINT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23028823 ↗
• MalfunctionMar 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 02/26/2024, IT WAS REPORTED BY A ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-6065-90 ROTATION LASSO GLUE ON THE TIP OF THE WIRE IS PEELING OFF. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896958 ↗
• MalfunctionMar 11, 2024Break; Break

  ON 2/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6065-90 ROTATION LASSO LABRAL REPAIR TIP BROKE OFF WITH NO FURTHER INFORMATION PROVIDED. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 2/27/2024: AR-6065-90 ROTATION LASSO LABRAL REPAIR TIP BROKE OFF INSIDE THE PATIENT WITH ALL FRAGMENTS REMOVED. THERE WAS NO CASE DELAY REPORTED. THE CASE WAS COMPLETED USING A DIFFERENT LASSO. THIS OCCURRED IN A BANKART REPAIR PROCEDURE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18878156 ↗
• MalfunctionMay 31, 2022Break

  ON 5/16/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-6065-90 ROTATION LASSO WIRE TIP BROKE. A NEW PRODUCT WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 14548270 ↗
• MalfunctionMar 2, 2021Break

  IT WAS REPORTED DURING A ROTATOR CUFF REPAIR, THE AR-6065-90 ROTATION LASSO WAS DEPLOYED TO SHUTTLE SUTURE, AS THE NITINOL WIRE WAS DEPLOYED AND THE SUTURE WAS CAPTURED, THE OUTER COATING OF THE NITINOL WIRE DISSOLVED AND THE LOOP BROKE IN HALF. THIS HAPPENED TO A TOTAL OF THREE AR-6065-90 (LOT: 0296107300) LASSOS THAT WERE OPENED DURING THE SAME PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11398179 ↗