Arthrex® AR-4068-45LRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00888867031470), received between Oct 30, 2019 and Sep 25, 2026 — classified as 2 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Break” (24 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break

  It was reported that during the shoulder arthroscopy, the tip of the device broke off. The broken piece was retrieved from the patient. 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 50899012 ↗
• MalfunctionSep 23, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869103 ↗
• MalfunctionSep 17, 2026Defective Device

  It was reported that during a meniscal ramp tear repair surgery 1 unit AR-4068-45L was used. Under the arthroscope, it appeared that the lasso had an issue. It looked like a suture had been sutured in or the lasso's sleeve had come loose. The product could be used, and the operation was completed successfully. Per complaint reporter there was no harm for patient, operator or third party. The surgery was finished successfully with the same device. It was not necessary to switch the surgical technique or do a second surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803746 ↗
• MalfunctionSep 10, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50712950 ↗
• MalfunctionSep 10, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50712870 ↗
• MalfunctionMar 19, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE SUTURES GOT TORN. 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 24640015 ↗
• MalfunctionMay 1, 2025Break; Break

  IT WAS REPORTED THAT DURING A BANKART REPAIR SURGERY THE LASSO BROKE WHEN SCRATCHING THE BONE. 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 21943767 ↗
• MalfunctionApr 22, 2025Material Separation; Material Separation

  ON 04/07/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6), AN AR-4068-45L SUTURELASSO SD, HAD AN ISSUE WITH THE NITINOL WIRE COATING BEING SEPARATED FROM THE NITINOL WIRE, CAUSING IT TO BECOME STUCK INSIDE THE CANNULA DURING USE. THE CASE WAS COMPLETED BY REMOVING THE COMPLAINT DEVICE FROM THE PATIENT AND BY USING A REPLACEMENT WITH NO ISSUES. THE CASE WAS DELAYED A FEW MINUTES AND NO ADDED ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A BANKART REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885318 ↗
• MalfunctionJan 29, 2025Break; Break

  ADDITIONAL INFORMATION WAS PROVIDED ON 08/12/2025 WHERE IT WAS STATED THIS CASE OCCURRED DURING SHOULDER SURGERY FOR GLENOHUMERAL INSTABILITY. IT HAPPENED WHEN DRILLING THE TENDON. THE SURGEON SAID THAT HE DID NOT USE MUCH FORCE TO DRILL THE TENDON, WHICH ENDED UP CRUSHING THE SUTURE LOOP. THERE WERE NO FRAGMENTS, MAINLY BECAUSE THE LOOP BROKE WHEN IT WAS UNTIED. ANOTHER SUTURE LOOP WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265392 ↗
• MalfunctionDec 13, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A REFIXATION LABRUM SURGERY THE NITINOL-LOOP WAS NOT ABLE TO BE MOVED AND GOT STUCK IN THE TIP. 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 20926197 ↗
• MalfunctionAug 7, 2024Break; Break

  ON 25TH JULY 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN (B)(6), SUTURELASSO¿ SD, 45° CURVE LEFT, THE END OF THE HEAD BROKE IN THE PATIENT. THIS WAS DETECTED DURING USE IN A REPAIR OF SHOULDER GLENOID LIP SURGERY ON (B)(6) 2024. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER PRODUCT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19930154 ↗
• MalfunctionJul 15, 2024Break; Break

  IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY THE TIP OF THE DEVICE BROKE OFF WHEN PIERCING THE TISSUE. ALL PARTS WERE RETRIEVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH ANOTHER DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19738931 ↗
• MalfunctionJul 15, 2024Break; Break

  IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY THE TIP OF THE DEVICE BROKE OFF WHEN PIERCING THE TISSUE. ALL PARTS WERE RETRIEVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH ANOTHER DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19738906 ↗
• MalfunctionJun 11, 2024Break; Break

  IT WAS REPORTED DURING INSERTION THE LASSO BROKE. IT WAS REPLACED AND THE SECOND ONE BROKE AS WELL. ALL WAS RETRIEVED. IT WAS REPLACED WITH A THIRD AR-4068-45L AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. THE PATIENT IS FINE TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19514952 ↗
• MalfunctionMay 28, 2024Break; Break

  IT WAS REPORTED THAT DURING BANKART SURGERY THE WIRES DID RIP OFF. THE DEVICES BROKE BEFORE IT WAS INSERTED INTO THE PATIENT¿S BODY. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19404022 ↗
• MalfunctionMay 28, 2024Break; Break

  IT WAS REPORTED THAT DURING BANKART SURGERY THE WIRES DID RIP OFF. THE DEVICES BROKE BEFORE IT WAS INSERTED INTO THE PATIENT¿S BODY. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19403980 ↗
• MalfunctionMay 14, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A SHOULDER LABRAL REPAIR THE TIP OF THE AR-4068-45L, SUTURE LASSO WOULD NOT ADVANCE INTO THE TISSUE. THE CASE WAS COMPLETED USING A DIFFERENT AR-4068-45L.

  Patient problems: Insufficient Information

  MAUDE report 19310631 ↗
• MalfunctionMar 15, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY THE DEVICE EASSILY GOT BENT IN THE JOINT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 18915420 ↗
• MalfunctionOct 9, 2023Break; Break

  IT WAS REPORTED THAT DURING A BANKART SURGERY THE SUTURE LASSO JAMMED IN THE PATIENT AND A PART OF THE DEVICE BROKE OFF. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 17897889 ↗
• MalfunctionSep 29, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE TIP OF THE DEVICE BROKE OFF DURING INSERTION. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. 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 17845001 ↗
• MalfunctionAug 2, 2023Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY THE LASSO COULD NOT BE PUSHED THROUGH THE DEVICE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 17443989 ↗
• MalfunctionJun 9, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-4068-45L SUTURE LASSO TIP BROKE OFF IN THE CANNULA. THIS WAS DISCOVERED DURING A CASE, DEVICE BREAKS DURING USE. PER FACILITY: ".SUTURE LASSO SD 45 DEGREE CURVE BEING USED IN KNEE SURGERY- 1 INCH PIECE OF TIP WITH CURVE BROKE OFF THE CANNULA. IT WAS RETRIEVED, NOTHING WAS LEFT IN THE PATIENT'S KNEE. ANOTHER SET WAS OPENED AND USED WITHOUT ANY CONCERN.".

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098609 ↗
• MalfunctionApr 11, 2023Break; Break

  ON THE (B)(6) 2023, IT WAS REPORTED VIA EMAIL THAT AN AR-4068-45L SUTURELASSO HAD AN ISSUE. THE DEVICE SNAPPED OFF INSIDE OF THE PATIENT'S SHOULDER DURING SURGERY WHILE TRYING TO BRING DEVICE BACK THROUGH THE PORT AS PER PROCEDURE NEEDS. THERE WAS A CASE AND PATIENT INVOLVED. THE TIP WAS ABLE TO BE LOCATED AND RETRIEVED SO NO ADVERSE EFFECT FOR PATIENT OCCURRED.

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

  MAUDE report 16713943 ↗
• MalfunctionFeb 16, 2023Break

  ON 31-JAN-2023, IT WAS REPORTED BY A SALES REP VIA EMAIL THAT THE NITINOL WIRE IN AN AR-4068-45L, SUTURELASSO, 45 DEGREE, CURVE LEFT SNAPPED. THIS WAS DISCOVERED DURING USE AND A CASE WAS INVOLVED. TO COMPLETE THE PROCEDURE, A S&N SUTURE SHUTTLE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 16386185 ↗
• MalfunctionFeb 16, 2023Break

  ON 31-JAN-2023, IT WAS REPORTED BY A SALES REP VIA EMAIL THAT THE NITINOL WIRE IN AN AR-4068-45L, SUTURELASSO, 45 DEGREE, CURVE LEFT SNAPPED. THIS WAS DISCOVERED DURING USE AND A CASE WAS INVOLVED. TO COMPLETE THE PROCEDURE, A S&N SUTURE SHUTTLE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 16386030 ↗