Arthrex® AR-6068-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888867038943), received between Aug 25, 2023 and Mar 17, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Break

  ON 23-FEB -2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-6068-90 LASSO LOOP BROKE WHEN IT WAS TURNED WITH TOO MUCH FORCE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617147 ↗
• MalfunctionFeb 23, 2026Break

  ON 04-FEB -2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-6068-90 LASSO TIP BROKE OFF. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO EXCESSIVE FORCE WAS APPLIED, AND THE DEVICE WAS USED NORMALLY. A NEW PRODUCT WAS OPENED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO HEALTH RISKS TO THE PATIENT, SUCH AS THE DEVICE REMAINING INSIDE THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414437 ↗
• MalfunctionJan 21, 2026Break

  ON (B)(6) 2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4). THAT AN AR-6068-90 90 DEG CURVE STRAIGHT, QUICKPASS LASSO TIP BROKE OFF IN THE GLENOHUMERAL JOINT DURING A RIGHT SHOULDER LABRAL REPAIR. THE CASE WAS DELAYED APPROXIMATELY 35 MINUTES IN ORDER TO RETRIEVE THE BROKEN TIP FROM THE AXILLARY POUCH OF THE GLENOHUMERAL JOINT, WHICH WAS DONE SO SUCCESSFULLY. THIS WAS DISCOVERED DURING THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 24131317 ↗
• MalfunctionJan 8, 2026Break

  ADDITIONAL INFORMATION PROVIDED 23-DEC-2025: IT WAS FURTHER REPORTED THAT THIS WAS DISCOVERED DURING ARTHROSCOPIC LABRAL REPAIR PROCEDURE WITH NO DELAY REPORTED NOR ADDITIONAL ANESTHESIA ADMINISTERED. NO FRAGMENTS WERE REPORTED INSIDE THE PATIENT. IT WAS REPORTED THAT WHILE ATTEMPTING TO PASS THE LASSO AROUND THE LABRUM TO RETRIEVE SUTURE, A LOUD CRACK WAS HEARD, NOTHING WAS OBSERVED INSIDE OF THE PATIENT. THE LASSO WAS REMOVED AND DISPOSED OF DUE TO THE NOISE. UPON EXAM IT WAS NOTED THE LASSO SEPARATED AT THE TOP WHERE THE METAL ATTACHES TO THE PLASTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004047 ↗
• MalfunctionJan 8, 2026Break

  ADDITIONAL INFORMATION PROVIDED 23-DEC-2025: IT WAS FURTHER REPORTED THAT THIS WAS DISCOVERED DURING ARTHROSCOPIC LABRAL REPAIR PROCEDURE WITH NO DELAY REPORTED NOR ADDITIONAL ANESTHESIA ADMINISTERED. NO FRAGMENTS WERE REPORTED INSIDE THE PATIENT. IT WAS REPORTED THAT WHILE ATTEMPTING TO PASS THE LASSO AROUND THE LABRUM TO RETRIEVE SUTURE, A LOUD CRACK WAS HEARD, NOTHING WAS OBSERVED INSIDE OF THE PATIENT. THE LASSO WAS REMOVED AND DISPOSED OF DUE TO THE NOISE. UPON EXAM IT WAS NOTED THE LASSO SEPARATED AT THE TOP WHERE THE METAL ATTACHES TO THE PLASTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003655 ↗
• MalfunctionOct 31, 2025Positioning Failure; Use of Device Problem; Positioning Failure; Use of Device Problem

  ON 10/22/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-6068-90 QUICKPASS LASSO WIRE LOOP BEGAN TO COME OUT FROM THE ROLLER AT THE HANDLE MIDWAY THROUGH THE PROCEDURE. BECAUSE THE HOSPITAL IS FAMILIAR WITH THIS PRODUCT, WE TRIED VARIOUS METHODS, INCLUDING RELOADING AND INSERTING IT FROM THE TIP, BUT IT WOULD NOT COME OUT PROPERLY FROM THE TIP, AND THE PROCEDURE WAS INTERRUPTED. THE USER OPENED A NEW PRODUCT AND PROCEEDED WITH THE PROCEDURE, WHICH WAS SUCCESSFULLY COMPLETED. THIS OCCURRED DURING USE IN A MENISCUS CENTRALIZATION CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434673 ↗
• MalfunctionMar 21, 2025Break; Break

  ON 03/11/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-6068-90 90° CURVE STRAIGHT BROKE WHEN THE TIP WAS INSERTED INTO THE ROTATOR CUFF. THE CASE WAS COMPLETED BY USING ANOTHER OF THE SAME PRODUCT. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 03/19/2025: THERE WAS NO CASE DELAY OR ADDED ANESTHESIA ADMINISTERED TO THE PATIENT. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THIS OCCURRED ON FIRST USE OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664028 ↗
• MalfunctionAug 22, 2024Flaked; Flaked

  ON (B)(6)2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4). THAT AN (B)(4). QUICKPASS LASSO COATING CAME OFF THE WIRE AND THE PRODUCT BECAME UNUSABLE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THIS CASE WAS COMPLETED BY NEW PRODUCT OF SAME PRODUCT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20044272 ↗
• MalfunctionJun 5, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED ON 11/11/2022 BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-6068-90 SUTURE LASSO WIRE GOT CAUGHT IN THE WHEEL AND RIPPED. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19471466 ↗
• MalfunctionMay 14, 2024Break; Break

  IT WAS REPORTED THAT DURING A RIGHT ARM SUBSCAP REPAIR SURGERY THE WIRE LOOP OF THE LASSO BROKE WHEN THE SURGEON PULLED SUTURES OUT. 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 19316144 ↗
• MalfunctionFeb 23, 2024Break; Break

  ON 02/06/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT WHILE USING QUICKPASS LASSO, AR-6068-90, DURING A ROOT REPAIR SURGERY ON (B)(6) 2024, THE TIP BROKE ON THE FIRST STITCH. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

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

  MAUDE report 18771673 ↗
• MalfunctionJan 3, 2024Material Fragmentation; Material Fragmentation

  ON 12/06/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE THAT AN AR-6068-90 QUICK PASS LASSO TIP OF THE SHAFT BROKE DURING USE. THE TIP WAS REMOVED AND THE CASE WAS COMPLETED USING A NEW PRODUCT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18437688 ↗
• MalfunctionSep 11, 2023Break; Break

  IT WAS REPORTED THAT DURING A RIGHT SHOULDER ARTHROSCOPIC POSTERIOR LABRAL REPAIR SURGERY THE TIP OF THE LASSO BROKE OFF WHILE TRYING TO PASS THE DEVICE THROUGH THE PATIENTS LABRUM. 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 17722920 ↗
• InjuryAug 25, 2023Break; Break

  IT WAS REPORTED THAT DURING A RIGHT SHOULDER ARTHROSCOPIC LABRAL REPAIR SURGERY THE TIP OF THE LASSO BROKE OFF WHILE ATTEMPTING TO PASS IT THROUGH THE PATIENTS ANTERIOR LABRAL. THE BROKEN-OFF TIP COULD NOT BE RETRIEVED AND REMAINS INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY BY SWITCHING THE PROCEDURE FROM AN ARTHROSCOPY TO AN OPEN PROCEDURE. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17624915 ↗