Arthrex® AR-6069-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867115934), received between Aug 29, 2022 and Aug 11, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 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.

• MalfunctionAug 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 07/24/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-6069-90 90-DEGREE REELPASS SUTURE LASSO FAILED. THE SURGEON WAS PERFORMING A SHOULDER LABRAL REPAIR. BEFORE THE CASE, THE PASSER WAS PREPPED BY EXPELLING A DECENT AMOUNT OF MONOFILAMENT AND CUTTING FLUSH. AFTER INTRODUCING THE REELPASS AND HOOKING IT UNDER THE LABRUM, HE ROLLED THE WHEELS TO EXPEL THE MONOFILAMENT. WHILE TRYING TO REMOVE THE PASSER, IT WAS FOUND THAT THE REELPASS WAS STUCK AND WOULD NOT EXPEL ANY MORE SUTURE. THE SURGEON TRIED TO PULL THE SUTURE FROM THE RETRIEVER MANUALLY, BUT NONE WOULD COME OUT. THE CASE WAS COMPLETED SUCCESSFULLY BY OPENING UP ANOTHER REELPASS. THE ITEM WAS DISPOSED OF AND WAS NOT AVAILABLE FOR RETURN.

  Patient problems: Insufficient Information

  MAUDE report 22777670 ↗
• MalfunctionMar 12, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 02/25/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-6069-90 REELPASS SUTURE LASSO WAS FED THROUGH A LITTLE BIT OF MONOFILAMENT BUT THEN STOPPED. THE DEVICE WAS REMOVED AND MONOFILAMENT MANUALLY PULLED OUT OF THE PASSER. THE PASSER WAS THEN TESTED WITH THE WHEELS BUT WOULD NOT EXPEL ANY MONOFILAMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY OPENING UP A NEW DEVICE. THIS OCCURRED DURING A LABRAL REPAIR WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21584758 ↗
• MalfunctionAug 29, 2022Break

  ON 08/10/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A AR-6069-90 REELPASS SUTURELASSO BROKE. THIS OCCURRED ON (B)(6) 2022 DURING AN UNKNOWN CASE. THE CASE WAS COMPLETED USING A DEVICE FROM ANOTHER MANUFACTURER. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15310720 ↗