Arthrex® AR-4068-45RRecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00888867031494), received between May 30, 2019 and Sep 23, 2026 — classified as 2 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Break” (33 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  On 08-Sep-2026, it was reported by an Arthrex Subsidiary Employee via (b)(4) that an AR-4068-45R 45° Curve Right SutureLasso tip became bent when using the instrument for the second anchor. The surgeon attempted to straighten it using a kelly clamp, and when reintroducing the device to pass through the labrum, the tip broke. This was discovered during a Shoulder Instability Repair with Knotless Pushlock procedure with no patient harm. No fragments remained in the patient. There was no delay to the procedure, and no additional anesthesia was required. The case was completed with another SutureLasso.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869611 ↗
• MalfunctionApr 14, 2026Break

  IT WAS REPORTED THAT DURING A SURGERY A PART OF THE DEVICE BROKE OFF. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24870767 ↗
• MalfunctionApr 11, 2026Break

  IT WAS REPORTED THAT DURING A SURGERY, 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 DESPITE A DELAY OF 5¿10 MINUTES. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851850 ↗
• 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 24640024 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT DURING A LABRUM FIXATION SURGERY THE TWO LASSOS AR-4068-45R (LOT: 5126159748) BROKE WHILE MOVING AROUND THE LABRUM. NO FRAGMENT REMAINED 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 24399851 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT DURING A LABRUM FIXATION SURGERY THE TWO LASSOS AR-4068-45R (LOT: 5126159748) BROKE WHILE MOVING AROUND THE LABRUM. NO FRAGMENT REMAINED 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 24399794 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT DURING A BANKART SURGERY THE TIP OF THE DEVICE BROKE. ALL PARTS WERE 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 24052185 ↗
• MalfunctionDec 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY SURGERY WHILE TRYING AFTER FEW ATTEMPTS TO PENETRATE THE SOFT TISSUE OF THE ANTERIOR INFERIOR SHOULDER CAPSULE THE HEAD OF THE LASSO WITH THE PENETRATING NEEDLE BROKE. THE SURGEON MANAGED TO PULL THE BROKEN PART OUTSIDE OF THE SHOULDER AND USED ANOTHER SAME LASSO AND SUCCEEDED WITH PENETRATING THE SOFT TISSUE. IT ENDED AS SHOULD WITH FIXING THE INSTABILITY. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862877 ↗
• MalfunctionDec 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED DURING THE KNEE ARTHROSCOPY THAT THE LASSO LOOP OF THE DEVICE 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 23693901 ↗
• MalfunctionNov 25, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE LASSO BROKE. 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 23647405 ↗
• MalfunctionAug 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A LABRUM RECONSTRUCTION SURGERY AFTER BANKART THE TIP BROKE. ALL PARTS WERE RETRIEVED. 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 22873709 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION SURGERY THE TIP OF THE DEVICE BROKE OFF. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECES. 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 21890807 ↗
• MalfunctionApr 18, 2025Dull, Blunt; Dull, Blunt

  ON 3RD APRIL 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT FOR AN AR-4068-45R, SUTURELASSO, 45 DEGREE CURVE RIGHT, THE SUTURE LASSO METAL TIP WAS BLUNT AND COULD NOT PENETRATE THE LABRAL TISSUE. THIS WAS DETECTED DURING USE IN AN ARTHROSCOPIC SHOULDER STABILISATION PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A NEW SUTURE LASSO WAS OPENED.

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

  MAUDE report 21864262 ↗
• MalfunctionFeb 10, 2025Break; Break

  ON 27TH JANUARY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-4068-45R, SUTURELASSO¿ SD, 45° CURVE RIGHT, THE TIP OF THE LASSO BROKE INSIDE PATIENT. THIS WAS DETECTED DURING USE IN AN ARTHROSCOPIC SHOULDER BANKART AND SLAP REPAIR PROCEDURE ON (B)(6) 2025. TIP WAS RECOVERED BUT HAD TO CREATE A BIG PORTAL TO GET IT OUT AND DELAYED THE PROCEDURE FOR ANOTHER 30 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE REPAIR WAS DONE SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344047 ↗
• MalfunctionJan 9, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR STABILISATION OF THE SHOULDER THE TIP OF THE DEVICE BROKE OFF. ALL PARTS WERE RETRIEVED. 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 21118702 ↗
• MalfunctionDec 13, 2024Failure to Advance; Failure to Advance

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-4068-45R, SUTURELASSO¿ SD, 45° CURVE RIGHT, THE LASSO LOOP WAS UNABLE TO THREAD THROUGH. THEY USED THE 2ND LASSO LOOP BUT WAS STILL UNABLE TO LOOP THROUGH. THIS WAS DETECTED DURING USE IN A RIGHT SHOULDER SLAP AND ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THEY OPENED AND USED A 2ND DISPOSABLE LASSO.

  Patient problems: Insufficient Information

  MAUDE report 20925923 ↗
• MalfunctionOct 9, 2024Break; Break

  IT WAS REPORTED THAT DURING A LABRUM FIXATION THE TIP OF THE DEVICE BROKE INSIDE 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. ***UPDATE DW 04-OCT-2024: FURTHER INFORMATION WAS PROVIDED THAT THE WIRE BROKE AT THE TIP BUT REMAINED INSIDE THE SHAFT. SO NOT PARTS HAD TO BE RETRIEVED OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20410697 ↗
• MalfunctionJun 28, 2024Break; Break

  IT AS REPORTED THAT DURING A LABRUM REFIX SURGERY THE TIP OF THE DEVICE BROKE OFF. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECES. 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 19639141 ↗
• MalfunctionJun 14, 2024Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE TIP OF THE LASSO BROKE OFF. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. A NEW LASSO WAS OPENED TO FINISH THE SURGERY SUCCESSFULLY. NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19538788 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED THAT DURING BANKART SURGERY THE LASSO BROKE OFF AT THE BENT TIP. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT. NO HARM OR ADVERSE EVENT 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19489620 ↗
• MalfunctionJan 25, 2024Break; Break

  ON 1/19/2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-4068-45R SUTURELASSO SD, 45-DEGREE CURVE RIGHT TIP BROKE OFF INSIDE OF RIGHT SHOULDER. THE TIP WAS NOT ABLE TO BE LOCATED. THE OPERATING ROOM WAS SEARCHED, AND MULTIPLE INTRAOPERATIVE X-RAYS WERE TAKEN; HOWEVER, THE TIP WAS NOT FOUND. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18580490 ↗
• MalfunctionNov 9, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS DEFECTIVE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE DW 23-OCT-2023. FURTHER INFORMATION WERE PROVIDED THAT WHEN THE SURGEON WAS PULLING OUT THE THREAD WITH THE LASSO, THE WIRE LOOP OF THE LASSO BROKE AT THE FRONT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18099905 ↗
• MalfunctionFeb 8, 2023Break

  IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION SURGERY THE TIP OF THE SUTURELASSO BROKE OFF INSIDE THE PATIENT. 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 16323445 ↗
• MalfunctionNov 16, 2022Break

  IT WAS REPORTED THAT DURING A LABRUM RE-FIX SURGERY, THE TIP BROKE OFF. 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 15803963 ↗
• MalfunctionApr 18, 2022Break

  DURING AN ARTHROSCOPIC STABILIZATION OF THE SHOULDER SURGERY THE NITINOL WIRE OF THE DEVICE BROKE WHEN THE SURGEON TRIED TO RETRIEVE THE SUTURE TROUGH THE CAPSULAR TISSUE. 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 14136571 ↗