Arthrex® AR-4068-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00888867031517), received between Apr 5, 2018 and Jul 10, 2026 — classified as 6 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Break” (23 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026Break

  IT WAS REPORTED THAT DURING THE SHOULDER ARTHROSCOPY, THE SHARP END OF THE DEVICE BROKE OFF. THE BROKEN PIECES 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 25778725 ↗
• MalfunctionMay 8, 2026Break

  ON (B)(6) 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-4068-90, SUTURELASSO¿ SD, 90° STRAIGHT, ITS SUTURE BROKE WHICH THE SURGEON COULD NOT USE ANYMORE. THIS WAS DETECTED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-4068-90. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 24TH APRIL 2026: THE NAME OF PROCEDURE PERFORMED WAS ROTATOR CUFF REPAIR OF THE SHOULDER JOINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25122971 ↗
• MalfunctionMar 5, 2026Positioning Failure

  ON 13-FEB-2026, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT A QTY. 7 OF AR-7250 FIBERWIRE #0, A QTY. 5 OF AR-7200 FIBERWIRE #2, A QTY. 1 OF AR-7535 FIBERLINK SUTURE TAPE WERE BEING CUT BY AN AR-12990N SCORPION NEEDLE DURING A MENISCAL ROOT REPAIR PROCEDURE. ANOTHER AR-12990N NEEDLE WAS OPENED BUT CONTINUED TO CUT THE SUTURES. AN AR-4068-90 SUTURE LASSO WAS THEN USED AS AN ALTERNATIVE TO TRY AND PASS THE SUTURES THROUGH TISSUE, BUT WAS ALSO UNSUCCESSFUL. THE CASE WAS COMPLETED SUCCESSFULLY WITH A SHOULDER SCORPION. NO PATIENT HARM WAS REPORTED, AND NO PIECES BROKE OFF INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523705 ↗
• MalfunctionJan 19, 2026Break

  IT WAS REPORTED THAT DURING THE SHOULDER SURGERY, THE TIP OF THE DEVICE BROKE OFF IN THE SHOULDER JOINT. THE BROKEN PIECES 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 24108312 ↗
• MalfunctionJan 12, 2026Break

  ON 23-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-4068-90 SUTURELASSO TIP BROKE OFF DURING USE. THIS WAS DISCOVERED DURING A SHOULDER BANKART REPAIR PROCEDURE WITH NO PATIENT HARM. THE BROKEN FRAGMENT WAS RETRIEVED FROM PATIENT, AND THE CASE WAS FINISHED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24039834 ↗
• MalfunctionDec 8, 2025Break; Break

  ON 11/17/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-4068-90 90° STRAIGHT SUTURELASSO BROKE WHEN THE DOCTOR TRIED TO PASS IT THROUGH THE LABRUM. THIS WAS DISCOVERED DURING A LABRUM REPAIR PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23742633 ↗
• MalfunctionOct 30, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 10/20/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA SEMS- (B)(4). THAT AN AR-4068-90 SUTURELASSOS NITINOL LOST ITS WAX COATING. THIS OCCURRED DURING A LABRAL TEAR REPAIR, DURING WHICH A SECOND SUTURELASSO WAS OPENED. IT WAS NECESSARY TO OPEN THE SECOND SUTURELASSO BECAUSE THE NITINOL FROM THE FIRST ONE GOT STUCK.

  Patient problems: Insufficient Information

  MAUDE report 23423284 ↗
• MalfunctionJul 14, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE THIN PLASTIC LAYER/PROTECTIVE COVER OF THE LASSO CAME LOOSE. 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 22494880 ↗
• MalfunctionMay 28, 2025Break; Break

  ON 04/30/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-4068-90 SUTURE LASSO TIP OF IT BROKE OFF IN THE PATIENT. THE SURGEON WAS ABLE TO VISUALIZE THE PIECE AND REMOVE IT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. PER FACILITY: "TO FURTHER CONFIRM A POST-OP X-RAY WAS PERFORMED AND FOUND TO BE NEGATIVE FOR ANY METALLIC FOREIGN BODY. " "THERE IS SOFT TISSUE SWELLING AND BUBBLES OF SOFT TISSUE GAS AROUND THE RIGHT SHOULDER AND IN THE SUPRACLAVICULAR REGION. NO METALLIC FOREIGN BODY IS SEEN. BONY ALIGNMENT IS NORMAL. THE JOINT SPACES ARE MAINTAINED." "SOFT TISSUE GAS, PRESUMABLY POSTOPERATIVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions; Swelling/ Edema

  MAUDE report 22095244 ↗
• MalfunctionMay 12, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-4068-90 SUTURELASSO SD BROKE WHILE REPAIRING THE LABRUM. THE BROKEN-OFF PIECE WAS RETRIEVED AND REMOVED FROM THE PATIENT. THIS WAS DISCOVERED DURING A LABRUM REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 05/05/2025: A NEW AR-4068-90 SUTURELASSO SD WAS USED TO COMPLETE THE CASE. THERE WAS NO CASE DELAY, AND NO ADDED ANESTHESIA WAS ADMINISTERED TO THE PATIENT. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002730 ↗
• MalfunctionMar 17, 2025Break; Break

  ON 3RD MARCH 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-4068-90, SUTURELASSO¿ SD, 90° STRAIGHT'S HEAD EXPERIENCED A SUDDEN BREAK IN THE JOINT CAVITY AFTER THE ANCHOR STITCHES PASS THROUGH THE TENDONS AT A NORMAL ANGLE. THIS HAPPENED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING A NEW AR-4068-90. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620104 ↗
• MalfunctionFeb 12, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY IT WAS FOUND THAT THE MANTLE OF THE SUTURE WIRE BECAME DETACHED. DUE TO THIS ISSUE THE WIRE LOST THE STIFFNESS WHICH MADE IT DIFFICULT TO USE. 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 21367430 ↗
• MalfunctionFeb 10, 2025Fitting Problem; Failure to Advance; Fitting Problem; Failure to Advance

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE WIRE COULD NOT BE GUIDED THROUGH THE DEVICE. 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 21343498 ↗
• MalfunctionOct 29, 2024Break; Break

  ON10/11/2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-4068-90 SUTURELASSO TIP BROKE IN THE PATIENT. THE BROKEN FRAGMENTS WERE REMOVED. AN X-RAY WAS TAKEN TO CONFIRM THE REMOVAL OF THE FRAGMENT. THIS WAS DISCOVERED DURING A PROCEDURE IN (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 20557487 ↗
• MalfunctionJul 9, 2024Break; Break

  ON 06/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-4068-90 SUTURELASSO END BROKE OFF. THIS OCCURRED DURING A SHOULDER ARTHROSCOPIC CAPSULAR PLICATION THE FRAGMENT WAS RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 19699809 ↗
• MalfunctionJun 21, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, THE SUTURE LASSO TORE. 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 19587482 ↗
• MalfunctionMay 23, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE DEVICE BECAME BENT. 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 19388659 ↗
• MalfunctionMay 20, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING A ROTATOR CUFF FIXATION SURGERY THE NITINOL WIRE LOOP OF THE DEVICE SPLICED (FRAYED) AT THE LASSO. A SECOND DEVICE WITH THE SAME LOT NUMBER WAS USED TO CONTINUE THE SURGERY AND THE SAME DEFECT ALSO OCCURRED WITH THE SECOND DEVICE. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A THIRD DEVICE WITH THE SAME PART NUMBER. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352023 ↗
• MalfunctionJan 10, 2024Material Fragmentation; Material Fragmentation

  ON 12/14/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE THAT AN AR-4068-90 SUTURE LASSO BROKE. WHILE ATTEMPTING TO PASS A 90 DEGREE SUTURELASSO THROUGH LABRAL TISSUE IN A GLENOID LABRUM REPAIR WITH {SURGEON}, THE END OF THE SUTURELASSO, WHERE IT BECOMES THINNER AND STARTS TO CURVE, BROKE OFF AND BECAME LODGED IN THE TISSUE. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18488842 ↗
• MalfunctionDec 22, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION SURGERY THE WIRE LOOP BROKE OFF WITHOUT MUCH FORCE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY 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 DW 24-NOV-2023. FURTHER INFORMATION WERE PROVIDED THAT EVERYTHING WAS RETRIEVED OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18382522 ↗
• MalfunctionJan 23, 2023Break

  ON (B)(6) 2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-4068-90 SUTURE LASSO BROKE DURING A BANKART REPAIR PROCEDURE. THE TIP OF THE DEVICE BROKE OFF. THE SURGEON RETRIEVED THE BROKEN PIECE AND COMPLETED THE PROCEDURE WITH NO FURTHER ISSUES.

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

  MAUDE report 16223425 ↗
• MalfunctionDec 12, 2022Break; Material Frayed; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING THE SHOULDER ARTHROSCOPY THE LASSO WAS ALREADY FRAYED AND THEN IT TEAR 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.

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

  MAUDE report 15964532 ↗
• MalfunctionNov 14, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-4068-90 SUTURELASSO TIP WAS DAMAGED WHILE INSIDE THE PATIENT. A NEW PRODUCT WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2022.

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

  MAUDE report 15788209 ↗
• MalfunctionJul 11, 2022Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE DEVICES BROKE DURING THE SURGERY. ALL BROKEN PARTS WERE 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 14976096 ↗
• InjuryJan 13, 2022Break

  IT WAS REPORTED BY A PATIENT'S FATHER THAT THE PATIENT HAD UNDERGONE AN ARTHROSCOPIC LABRUM REPAIR PROCEDURE ON (B)(6) 2018. UPON COMPLETION OF THE PROCEDURE THE PATIENT AND HIS MOTHER WERE INFORMED THAT DURING THE PROCEDURE, WHEN PLACING THE SECOND ARTHREX SUTURETAK ANCHOR, THE 90 DEGREE SUTURE LASSO BROKE. SURGEON LOCATED THE DEVICE AND ATTEMPTED TO RETRIEVE BUT WAS UNSUCCESSFUL. THE SURGEON CONTINUED WITH THE PROCEDURE, COMPLETING IT ARTHROSCOPICALLY. THE DEVICE FRAGMENT WAS LEFT IN THE LABRAL CAPSULE AND WAS REPORTED TO BE APPROXIMATELY 1/2 CM IN LENGTH. PATIENT'S FATHER REQUESTED THAT THE FACILITY RETAIN THE 90 DEGREE SUTURE LASSO INSTRUMENT FOR FUTURE INVESTIGATION/EVALUATION. IT IS UNKNOWN IF THE DEVICE WAS RETAINED AS REQUESTED. ADDITIONAL INFORMATION OBTAINED 2/13/19: ACCORDING TO ADDITIONAL INFORMATION PROVIDED BY THE PATIENT¿S FATHER THE SURGEON STATED THAT HE DID NOT WANT TO JEOPARDIZE THE STABILITY OF THE SHOULDER BY OPENING OR TAKING DOWN THE LABRAL CAPSULAR COMPLEX ARTHROSCOPICALLY. POST-OP X-RAYS WERE USED TO MONITOR THE SUTURE LASSO TIP. REPORT FURTHER STATED THAT IF THE SUTURE LASSO TIP MOVED, THEN THE SURGEON WOULD MOST LIKELY PROCEED WITH A SECOND SURGERY TO REM

  Patient problems: Foreign Body In Patient

  MAUDE report 13254152 ↗