Arthrex® AR-9596-1025FRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867346109), received between Feb 11, 2025 and Jun 10, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 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.

• MalfunctionJun 10, 2025Naturally Worn; Naturally Worn

  ON 04/30/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9596-1025F INSTRUMENT IS WORN DOWN. ISSUE OCCURRED DURING A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION: DRILL WOULD NOT CONNECT TO THE DRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176373 ↗
• MalfunctionFeb 11, 2025Break; Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9596-1025F MODULAR DRILL BROKE. THIS OCCURRED DURING A CASE AND CAUSED NO ISSUES FOR THE PATIENT. ADDITIONAL INFORMATION WAS PROVIDED ON 01/23/2025, WHERE THE SALES REPRESENTATIVE STATED THAT THIS EVENT OCCURRED DURING A REVERSE PROCEDURE ON (B)(6) 2025. THE DEVICE BROKE WHILE BEING USED. THE PATIENT HAD A FAIR BONE QUALITY. ALL FRAGMENTS WERE ABLE TO BE RETRIEVED FROM THE PATIENT. THERE WAS NO DELAY IN THE PROCEDURE, AND NO ADDITIONAL ANESTHESIA NEEDED TO BE ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 21356277 ↗