Arthrex® AR-SOV-R30-330Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867503212), received between May 28, 2025 and Feb 16, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING THE SPINE SURGERY, THE SURGEON HAD NO ARTHROSCOPIC VIEW WHEN USING THE DEVICE WITH SUCTION AND PUMP, AS THE DEVICE CAUSED SEVERE TURBULENCE IN AIR BUBBLES. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343741 ↗
• InjuryMay 28, 2025Unintended Movement; Unintended Movement

  ON 05/07/2025, AN ARTHREX EMPLOYEE REPORTED VIA EMAIL, WHICH WAS CAPTURED IN (B)(4), THAT AR-SOV-R30-330, A 3 X 330MM OVAL BUR DISPOSABLE BLADE, WAS USED ON A SHAVER IN A UNILATERAL LAMINOTOMY FOR BILATERAL DECOMPRESSION (ULBD). THE BLADE SKIPPED ON THE CORTICAL BONE AT THE ROSTRAL EDGE OF THE L5 LAMINA AND CREATED A SMALL DUROTOMY. IT WAS REPAIRED, AND THE PATIENT IS DOING FINE. THE CASE WENT SMOOTHLY. THE CASE WAS COMPLETED WITH NO FURTHER COMPLICATIONS. THE BLADE WAS DISPOSED OF AND IS NOT AVAILABLE FOR RETURN.

  Patient problems: Dural Tear

  MAUDE report 22096015 ↗