Arthrex® AR-6068-45RRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00888867038936), received between Apr 8, 2020 and Jul 6, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE STABILIZATION SURGERY, THE TIP OF THE DEVICE FIRST BENT AND SUBSEQUENTLY BROKE OFF. THE TIP DID NOT BREAK OFF INSIDE 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 25725192 ↗
• MalfunctionDec 22, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 12/01/2025, A DISTRIBUTOR REPORTED VIA (B)(4) THAT AN AR-6068-45R 45-DEGREE RIGHT-CURVED QUICKPASS LASSO BENT UPON PASSING THE LABRUM DURING A BANKART PROCEDURE, WHICH WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863098 ↗
• MalfunctionJul 25, 2025Break; Break

  IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY, THE TIP OF THE DEVICE BROKE OFF INSIDE THE PATIENT WHEN THE SURGEON PIERCED THE LABRUM. THE BROKEN PART WAS RETRIEVED FROM THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-4068-25TR). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

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

  MAUDE report 22608854 ↗
• MalfunctionJan 6, 2025Material Frayed; Failure to Advance; Material Frayed; Failure to Advance

  ON 12/10/2024, A SALES REPRESENTATIVE VIA (B)(4) REPORTED THAT AN AR-6068-45R 45°, CURVE, RIGHT, QUICKPASS LASSO HAD AN ISSUE. THE SURGEON COULD NOT TURN THE WHEEL AND ADVANCE THE WIRE AS THOUGH IT WAS STUCK. NO DAMAGE OR HARM WAS CAUSED TO THE PATIENT. NO CASE DELAY WAS REPORTED, AN ADDITIONAL LASSO WAS USED, AND THE CASE PROCEEDED AS NORMAL. THIS WAS DISCOVERED DURING A LABRAL REPAIR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. PER THE REP, UPON EXAMINATION OF THE DEFECTIVE LASSO, "AFTER THE CASE WAS OVER, WE HAD THE TECH EXAMINE THE DEFECTIVE LASSO ON THE BACK TABLE AND IT LOOKED LIKE THE WIRE WAS FRAYED INSIDE OF THE LASSO HANDLE ITSELF WHICH WAS WHAT PREVENTED THE WHEEL FROM TURNING." ADDITIONAL INFORMATION WAS RECEIVED ON 12/14/2024: THIS WAS NOT A RELOAD BUT ON THE DEVICE'S FIRST USE. THE DEVICE IS NOT AVAILABLE FOR RETURN AS THEY TOOK IT APART ON THE BACK TABLE AND THEN DISPOSED OF IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21084773 ↗
• MalfunctionJun 14, 2024Failure to Advance; Failure to Advance

  ON 02/23/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-6068-45R QUICKPASS LASSO WOULD NOT FEED THE WIRE LOOP THROUGH THE TIP. IT WAS ATTEMPTED TO WHEEL THE WIRE LOOP OUT OF THE END OF THE LASSO BUT IT WOULD NOT FEED. THIS OCCURRED DURING A CASE BUT NEVER MADE IT TO THE PATIENT. AN AR-4068-45R SUTURELASSO WAS USED A AR-6068-45R AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION IS REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED ON 02/27/2023, IT WAS REPORTED THAT THIS OCCURRED DURING A SHOULDER INSTABILITY LABRAL REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19542962 ↗
• MalfunctionJun 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-6068-45R QUICKPASS LASSO FRAYED. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19497954 ↗
• MalfunctionMay 28, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT, DURING A LABRUM SWIVEL LOCK SURGERY, THE SUTURE OF THE AR-6068-45R QUICKPASS LASSO COULDN`T BE PUSHED THROUGH THE WHEEL. 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 19403948 ↗
• MalfunctionMar 28, 2024Break; Break

  IT WAS REPORTED THAT DURING A SURGERY A 2MM PIECE OF THE NEEDLE TIP BROKE OFF AND WAS RETAINED IN THE PATIENT AS THE RISK OF INJURY WAS HIGHER IF THE SURGEON TRIED TO REMOVE IT. NO FURTHER INFORMATION RECEIVED. UPDATE DW 14-MAR-2024: FURTHER INFORMATION WERE PROVIDED THAT 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: Foreign Body In Patient

  MAUDE report 18993926 ↗
• MalfunctionMar 26, 2024Break; Break

  ADDITIONAL INFORMATION: FURTHER INFORMATION WAS PROVIDED THAT A SECOND SURGERY WAS PERFORMED, AND THE TIP COULD BE REMOVED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18982014 ↗
• MalfunctionFeb 14, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS PROVIDED ON 2/5/2024 WHERE THE SALES REPRESENTATIVE STATED THAT THIS EVENT OCCURRED IN A LABRAL REPAIR ON(B)(6) 2024. THE LASSO WIRE WITHIN THE LASSO WOULD NOT ENGAGE WITH THE THUMBWHEEL. ANOTHER AR-6068-45R WAS OPENED TO PROCEED WITH THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18703937 ↗
• MalfunctionJun 5, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC BANKART SURGERY THREE DEVICES FAILED. FROM ONE DEVICE THE TIP BROKE OFF AND THE TIP OF THE OTHER TWO DEVICES GOT BEND. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. THE SURGEON HAD TO SEARCH FOR THE PART IN THE SHOULDER THAT BROKE OFF. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE FROM ANOTHER MANUFACTURER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17057611 ↗
• MalfunctionMay 16, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-6068-45R QUICKPASS LASSO BROKE. THIS OCCURRED DURING A BANKART REPAIR ON 04/26/2023, THE BROKEN FRAGMENTS WERE RETRIEVED. A NEW LASSO WAS OPENED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16939152 ↗
• MalfunctionMay 15, 2023Break; Break

  IT WAS REPORTED THAT DURING SHOULDER CAPSULOPLASTY ARTHROSCOPY, THE TIP OF THE SUTURLASSO BROKE OFF INSIDE THE JOINT WHEN THE SURGEON TRIED TO PASS THE LABRUM. 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. UPDATE SWIT (B)(6) 2023: THE TIP OF THE INSTRUMENT BROKE OFF. IT WAS NOT EASY TO REMOVE FROM THE JOINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16931303 ↗
• MalfunctionMar 28, 2022Break

  ON 03/10/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-6068-45R FASTPASS LASSO BROKE. THIS OCCURRED ON (B)(6) 2022 DURING A LABRAL REPAIR WHILE PASSING THE LASSO THROUGH THE TISSUE THE TIP BROKE AT THE "NECK". THE BROKEN PIECE WAS RETRIEVED, AND THE CASE WAS COMPLETED USING A NEW ONE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13928554 ↗
• MalfunctionJan 18, 2022Break

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THE TIP OF THE AR-6068-45R LASSO BROKE.

  Patient problems: Insufficient Information

  MAUDE report 13281585 ↗
• MalfunctionJan 4, 2022Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, LABRAL REPAIR SURGERY THE HOOK TIP OF THE SUTURE LASSO HAD BROKEN OFF WITHIN A PATIENT'S SHOULDER. THE LOOSE SHARP CURVED TIP WAS REMOVED FROM THE JOINT. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS 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: Insufficient Information

  MAUDE report 13154582 ↗
• MalfunctionMay 24, 2021Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BANKART SURGERY, ONE LASSO GOT BENT AND ONE BROKE-OFF INSIDE THE PATIENT BUT IT WAS RETRIEVED FROM THE PATIENT. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. ***UPDATE 05-MAY-2021: A NEW DEVICE FROM ANOTHER MANUFACTURER WAS USED TO FINISH THE SURGERY SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11871639 ↗
• MalfunctionMar 8, 2021Break

  IT WAS REPORTED THAT WHEN THE SURGEON INSERTED THE LASSO, AR-6068-45R, INTO THE TISSUE, THE LASSO BROKE. THE SURGEON DID NOT USE ANY EXTRA FORCE. A NEW LASSO WAS OPENED AND USED TO COMPLETE THE CASE WITH NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11436528 ↗
• InjuryApr 8, 2020Break

  IT WAS REPORTED THAT THE LASSO TIP BROKE OFF INSIDE THE PATIENT. THE SURGEON PERFORMED AN ADDITIONAL OPEN APPROACH AND WAS ABLE TO RETRIEVE THE PART OUT OF THE PATIENT AND PROCEEDED THE OPEN REPAIR OF BONY BANKART AND STABILIZATION. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY. ADDITIONAL INFORMATION OBTAINED 30-MAR-2020: FURTHER INFORMATION WERE RECEIVED THAT THE SURGEON HAD CHANGED THE PROCEDURE TO AN OPEN PROCEDURE TO RETRIEVE THE MISSING PARTS OUT OF THE PATIENT. NO ADDITIONAL SURGERY WAS PERFORMED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9935780 ↗