Arthrex® AR-9202-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867058378), received between Jun 28, 2021 and Jul 9, 2024 — classified as 3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2024Break; Break

  ON 06/13/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9202-13 IMPACTOR HANDLE WAS BROKEN. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19700390 ↗
• MalfunctionJun 14, 2024Break; Break

  IT WAS REPORTED ON 02/21/2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9202-13 IMPACTOR HANDLE BROKE OFF. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19541774 ↗
• MalfunctionJun 28, 2021Break

  IT WAS REPORTED THAT DURING A ECLIPSE TOTAL SHOULDER ARTHROPLASTY, THE HANDLE OF THE AR-9202-13 BROKE. NO PATIENT HARM AND THE CASE WAS COMPLETED BY USING A NEW AR-9202-13.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12076189 ↗