Arthrex® AR-9300DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867211834), received between Sep 21, 2021 and Sep 23, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Material Fragmentation

  It was reported that during an arthroscopic wrist surgery the device produced metal shaving while removing remnants of the SL ligament that prolapsed into the joint. The surgeon tried to remove the metal shaving, but he did not succeed. Some fragments remained in the patient's knee. 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: Foreign Body In Patient

  MAUDE report 50866746 ↗
• MalfunctionMar 9, 2026Break

  ON 16-FEB-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-9300DS DISSECTOR HAD THE MICRO TEETH BREAK. THIS WAS DISCOVERED DURING A HAND ARTHROSCOPY PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544088 ↗
• MalfunctionJan 24, 2024Defective Device; Defective Device

  ON 5TH JANUARY 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-9300DS, DISSECTOR, SMALL HUB, 3.0 MM X 7 CM, HAD A MANUFACTURING PROBLEM. THIS WAS DETECTED DURING AN ARTHROSCOPIC ANKLE AND LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(4) 2024. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE SURGEON DECIDED TO USE SABRE.

  Patient problems: Insufficient Information

  MAUDE report 18574318 ↗
• MalfunctionSep 21, 2021Break; Dull, Blunt

  IT WAS REPORTED ON (B)(6) 2021 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-9300DS DISSECTORS TEETH ARE DULLING AND METAL SHAVINGS ARE BREAKING OFF INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12507564 ↗