Arthrex® AR-4068-25TRRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00888867031449), received between Feb 21, 2019 and Apr 21, 2025 — classified as 2 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY THE WIRE SNAPPED ON THE FIRST DETOUR. 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 21871972 ↗
• MalfunctionJan 28, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A BANKART SUTURE SURGERY THE SUTURE DID NOT COME OUT OF THE SHAFT. 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 21251845 ↗
• MalfunctionJun 18, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPIC PROCEDURE, THE SURGEON NOTICED THAT THE NITINOL WIRE WAS BENT AND COULD NOT BE USED. THE CASE WAS COMPLETED BY USING A NEW AR-4068-25TR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19562823 ↗
• MalfunctionJun 17, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY SURGERY THE LASSO COULD NOT HAVE BEEN PULLED BACK AND GOT STUCK. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547082 ↗
• MalfunctionJun 13, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 8/26/2021 IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-4068-25TR SUTURELASSO¿ SD, 25° TIGHT CURVE RIGHT COULD NOT GET THE NITINOL WIRE INSERTED, IT APPEARED TO BE COVERED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021, NO PATIENT AFFECTED. ADDITIONAL INFO RECEIVED 9/10/2021 THE NITINOL GUIDE WIRE NEVER MANAGED TO BE INSERTED THROUGH DEVICE, SURGEON ATTEMPTED TO COMPLETED CASE USING INSTRUMENTS FROM THE ACTUAL FACILITY. THIS WAS DISCOVERED DURING A RCR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528760 ↗
• MalfunctionJun 12, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A LABRUM BANKART SHOULDER SURGERY THE LASSO WIRE OF THE DEVICE WAS BENT AND DUE TO THE LACK OF STIFFNESS THE LASSO WIRE COULD NOT BE PUSHED FURTHER. NO PART OF THE DEVICE BROKE INSIDE THE PATIENT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 19518640 ↗
• MalfunctionJun 12, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A LABRUM BANKART SHOULDER SURGERY THE LASSO WIRE OF THE DEVICE WAS BENT AND DUE TO THE LACK OF STIFFNESS THE LASSO WIRE COULD NOT BE PUSHED FURTHER. NO PART OF THE DEVICE BROKE INSIDE THE PATIENT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 19518597 ↗
• MalfunctionJun 12, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SLAP LESION SHOULDER SURGERY THE LASSO WIRE OF THE DEVICE WAS BENT AND DUE TO THE LACK OF STIFFNESS THE LASSO WIRE COULD NOT BE PUSHED FURTHER. NO PART OF THE DEVICE BROKE INSIDE THE PATIENT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 19518554 ↗
• MalfunctionJun 4, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE SUTURE LASSO LOOP COULD NOT BE MOVED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 19459274 ↗
• MalfunctionMay 24, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 04/26/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-4068-25TR SUTURELASSO INTERNAL NITINOL OF THE DOES NOT SLIDE, SO IT IS NOT POSSIBLE TO RESCUE THE SUTURES (IT DOES NOT FULFILL ITS FUNCTION). THIS OCCURRED DURING A SHOULDER ARTHROSCOPY WHERE ANOTHER DEVICE WAS USED TO PROCEED.

  Patient problems: Insufficient Information

  MAUDE report 19395786 ↗
• MalfunctionMay 9, 2024Break; Break

  ON 04/15/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-4068-25TR SUTURE LASSO WIRE BROKE AFTER SHUTTLING ONE SUTURE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO PATIENT HARM WAS CAUSED AND ANOTHER LASSO WAS OPENED FOR SUBSEQUENT PASSES. ALL OF THE WIRE WAS RETRIEVED AND NONE WAS LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19276718 ↗
• MalfunctionApr 23, 2024Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT DURING A LABRUM SLAP REPAIR SHOULDER SURGERY THE LASSO WIRE OF THE DEVICE WAS BENT AND DUE TO THE LACK OF STIFFNESS THE LASSO WIRE COULD NOT BE PUSHED FURTHER. NO PART OF THE DEVICE BROKE INSIDE THE PATIENT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 19163803 ↗
• MalfunctionJan 25, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LABRUM-REFIX SURGERY WITH PUSH LOCK THE WIRE LOOP TORE DUE TO THE PULLING FORCE WHEN SHUTTLING THE SUTURE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 18580362 ↗
• MalfunctionMay 10, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE RING IN FRONT OF THE DEVICE BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS 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 16904860 ↗
• MalfunctionMar 17, 2023Break; Break

  IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY, THE DEVICE BROKE OFF. THERE WAS NO HARM TO THE 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564940 ↗
• MalfunctionFeb 8, 2023Break

  IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY THE TIP OF THE DEVICE BROKE OFF. ALL BROKEN PARTS COULD BE RETRIEVED FROM THE PATIENT. 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 16323768 ↗
• MalfunctionDec 2, 2022Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE DEVICE BROKE OFF. 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 (B)(6) 2022: THE DEVICE BROKE IN THE PATIENT AND EVERYTHING WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15905285 ↗
• MalfunctionNov 28, 2022Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE TIP OF THE LASSO BROKE OFF AT THE CURVED PART. AN ARTHROTOMY HAD TO BE PERFORMED TO REMOVE THE BROKEN TIP AND NO BROKEN OFF PARTS REMAINED INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15868719 ↗
• MalfunctionApr 4, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-4068-25TR SUTURELASSO SD WAS PASSED THROUGH THE TISSUE AND THE TIP BROKE. SURGEON REMOVED THE BROKEN FRAGMENT AND CONTINUED THE CASE USING TWEEZERS TO PASS THE TISSUE. THIS WAS DISCOVERED DURING RIGHT SHOULDER ARTHROSCOPY ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13994946 ↗
• MalfunctionFeb 28, 2022Break

  IT WAS REPORTED THAT DURING A BANKART SURGERY THE TIP OF THE LASSO BROKE OFF. 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 (B)(6) 2022: THE TIP OF BOTH LASSO´S BROKE OFF INSIDE THE PATIENT, BUT WERE RETRIEVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620616 ↗
• MalfunctionFeb 7, 2022Break

  IT WAS REPORTED THAT DURING A BANKART SURGERY THE TIP OF THE LASSO BROKE OFF. 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 (B)(6) 2022: THE TIP OF BOTH LASSO´S BROKE OFF INSIDE THE PATIENT, BUT WERE RETRIEVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13471373 ↗
• MalfunctionJan 24, 2022Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A BANKART SURGERY WHEN THE SURGEON GRABBED THE WIRE WITH THE BARREL PLIERS AND THEN PULLED IT OUT, THE WIRE WAS TORN. THERE WAS 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 13333586 ↗
• MalfunctionJan 24, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-4068-25TR SUTURE LASSO TIP BROKE OFF INSIDE OF THE JOINT. THIS OCCURRED DURING AN UNKNOWN PROCEDURE. THE FRAGMENT WAS FULLY RETRIEVED. THERE WAS NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13333331 ↗
• MalfunctionJan 7, 2022Break

  ON (B)(6) 2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA E-MAIL THAT AN AR-4068-25TR SUTURELASSO BROKE. THIS OCCURRED ON (B)(6) 2021 DURING A SHOULDER PROCEDURE WHEN THE SURGEON MANIPULATED THE SUTURELASSO INTO THE PATIENT AND IT BROKE. THE FRAGMENTS WERE RETRIEVED, AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION PROVIDED ON 12/21/2021 : THE PROCEDURE BEING PERFORMED WAS AN INSTABILITY. THE SUTURE BROKE, AND THE FRAGMENT WAS ABLE TO BE RETRIEVED. THE CASE WAS COMPLETED USING THE BIRD'S BEAK FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13189879 ↗
• MalfunctionAug 10, 2021Break

  IT WAS REPORTED THAT DURING A ABR PROCEDURE, THE WIRE INSIDE BROKE BEFORE THE FORCE WAS APPLIED IMMEDIATELY. THE PART WHERE THE THICKNESS CHANGES WAS BROKEN. THE CASE WAS COMPLETED BY USING A NEW PRODUCT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12300422 ↗