NA 388.349Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034772486), received between Feb 16, 2017 and Feb 16, 2017 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2017Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT TEN (10) BROKEN DEVICES WERE RECEIVED BY SERVICE AND REPAIR WITH NO INFORMATION REGARDING HOW OR WHEN THE DEVICES WERE BROKEN. THERE WAS NO REPORT OF PATIENT OR SURGICAL INVOLVEMENT. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6338140 ↗