Arthrex® AR-18700-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867316188), received between Jun 6, 2022 and Jul 23, 2024 — classified as 2 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. 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.

• MalfunctionJul 23, 2024Break; Break

  ON 07/04/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-18700-03 DRIVER SHAFT CRUCIATE TIP OF SCREWDRIVER BROKE WHEN SCREWING IN THE SCREW. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19808590 ↗
• MalfunctionJun 6, 2022Break; Degraded; Mechanical Problem

  ON 04/18/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT (2) AR-18700-03 DRIVER SHAFTS ARE RUSTED, AND STRIPPED. ALSO A AR-18700-29 DRIVER SHAFT HALF OF THE TIP BROKE OFF. THIS WAS DISCOVERED ON (B)(6) 2022 DURING A ULNA AND RADIUS ORIF. THE CASE WAS COMPLETED USING A MOSQUITO CLAMP AS THERE WAS NO OTHER DRIVER AVAILABLE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14602977 ↗