Arthrex® AR-4068CRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867031555), received between Jun 14, 2018 and Oct 23, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2018Break

  IT WAS REPORTED THAT, WHILE PIERCING THROUGH THE LABRUM WITH THE AR-4068C IN A SHOULDER LABRAL REPAIR PROCEDURE, THE TIP OF THE SUTURE LASSO BROKE OFF IN THE LABRUM NEAR THE BASE OF THE BICEPS. THIS OCCURRED WHILE THE SURGEON WAS ATTEMPTING TO PASS THE LAST SUTURE. THE SURGEON MADE AN ADDITIONAL PORTAL AND WAS ABLE TO EFFICIENTLY AND FULLY REMOVE THE BROKEN PIECE. THE PROCEDURE WAS COMPLETED, AND AN ADDITIONAL SURGERY IS NOT REQUIRED. THIS OCCURRED DURING THE INITIAL/FIRST TIME USE OF THE DEVICE.

  Patient problems: No Code Available

  MAUDE report 7994467 ↗
• InjuryJun 14, 2018Bent; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY CASE, AFTER THE CRESCENT SUTURELASSO, AR-4068C, HAD BEEN BENT MULTIPLE TIMES BY THE SURGEON, THE TIP BROKE OFF IN THE GLENOHUMERAL JOINT OF THE PATIENT AND NEEDED TO BE RETRIEVED. THE BROKEN PIECE OF THE SUTURELASSO WAS APPROXIMATELY AN INCH LONG. THE SURGEON ATTEMPTED TO RETRIEVE THE PIECE USING FLUOROSCOPY DURING THE ORIGINAL SURGERY BUT WAS UNABLE TO RETRIEVE THE PIECE ARTHROSCOPICALLY. A SECOND SURGERY WAS SCHEDULED AT A DIFFERENT HOSPITAL THE SAME DAY FOR THE REMOVAL OF THE SUTURELASSO FRAGMENT BY THE SAME SURGEON. IT WAS CONFIRMED THAT THE SECOND SURGERY TOOK PLACE AND THE SUTURELASSO FRAGMENT WAS RETRIEVED.

  Patient problems: No Information

  MAUDE report 7600209 ↗
• InjuryJun 14, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THAT DURING A CASE, AFTER THE CRESCENT SUTURELASSO, AR-4068C, HAD BEEN BENT MULTIPLE TIMES BY THE SURGEON, THE TIP BROKE OFF IN THE GLENOHUMERAL JOINT OF THE PATIENT AND NEEDED TO BE RETRIEVED. PRIOR TO BREAKAGE, THE SURGEON FORCED THE LASSO TO BEND AT THE TIP MULTIPLE TIMES BY PUSHING IT INTO A METAL INSTRUMENT TRAY AND ALSO USING A NEEDLE DRIVER TO MANIPULATE THE TIP OF IT. THE BROKEN PIECE OF THE SUTURELASSO WAS APPROXIMATELY AN INCH LONG. THE SURGEON ATTEMPTED TO RETRIEVE THE PIECE USING FLUOROSCOPY BUT WAS UNABLE TO RETRIEVE THE PIECE ARTHROSCOPICALLY. THE SURGERY LASTED APPROXIMATELY 4 - 4 1/2 HOURS. A SECOND SURGERY WAS SCHEDULED AT A DIFFERENT HOSPITAL THE SAME DAY FOR THE REMOVAL OF THE SUTURELASSO FRAGMENT BY THE SAME SURGEON (ARTHREX REFERENCE (B)(4)). THE NEEDLE DRIVER (PART AND LOT NUMBER UNKNOWN) THAT WAS USED TO TRY AND BEND THE SUTURELASSO BROKE DURING THE ATTEMPT. THIS OCCURRED OUTSIDE THE PATIENT FIELD AND THE NEEDLE DRIVER BROKEN PIECE WAS ACCOUNTED FOR. FOLLOW-UP INVESTIGATION: TYPE OF PROCEDURE BEING PERFORMED WAS A SHOULDER ARTHROSCOPY WITH CAPSULORRAPHY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7600202 ↗