Arthrex® AR-4068-05SDRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867031418), received between Feb 7, 2022 and Sep 23, 2026 — classified as 7 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  It was reported that during a rotator cuff repair surgery the wire 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 50871734 ↗
• MalfunctionSep 23, 2026Break

  It was reported that during a rotator cuff repair surgery the wire 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 50871488 ↗
• MalfunctionJan 12, 2026Material Frayed

  ON 25-DEC-2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT 2 AR-4068-05SD SUTURE LASSOS SUTURES BECAME FRAYED AND UNUSABLE WHEN TIGHTENING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO DELAY IN CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037965 ↗
• MalfunctionJan 12, 2026Material Frayed

  ON 25-DEC-2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT 2 AR-4068-05SD SUTURE LASSOS SUTURES BECAME FRAYED AND UNUSABLE WHEN TIGHTENING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO DELAY IN CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037546 ↗
• MalfunctionNov 3, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT FOR AN AR-4068-05SD, SUTURELASSO¿ SD WIRE LOOP, WHILE USING THE MICROLASSO, THE LASSO SNAPPED. WHEN THE NEW SD WIRE LOOP WAS OPENED, IT WAS EMPTY. THIS WAS DETECTED DURING USE IN A F&A ATFL PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THEY OPENED ANOTHER SD WIRE LOOP.

  Patient problems: Insufficient Information

  MAUDE report 23449886 ↗
• MalfunctionJul 9, 2025Material Fragmentation; Peeled/Delaminated; Material Fragmentation; Peeled/Delaminated

  ON 17TH JUNE 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-4068-05SD, SUTURELASSO¿ SD WIRE LOOP, THE WIRE COATING PEELED OFF WILE RELAYING AFTER SUTURE PASSING. THERE WAS A DELAY OF ABOUT 20 MINUTES IN REMOVING THE PEELING COATING FROM THE PATIENT'S BODY. THIS WAS DETECTED DURING AN ARTHRO BROSTROM SURGERY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING A REPLACEMENT PRODUCT OF AR-4068-05SD. THERE WAS NO PATIENT HARM.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22463321 ↗
• MalfunctionFeb 7, 2022Disconnection; Failure to Advance

  THE SURGEON WAS USING THE SWIFT STITCH TO PASS A SUTURE THROUGH THE LABRUM OF THE HIP. HE MADE ONE PASS AND WHEN HE BROUGHT THE INSTRUMENT OUT OF THE TRIM IT CANNULA, THE TEETH WOULD NOT ADVANCE AS THE SHEATH HAD DISCONNECTED FROM THE SHAFT OF THE SWIFT STITCH.

  Patient problems: Insufficient Information

  MAUDE report 13471392 ↗