NA 388.521Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034773377), received between Mar 21, 2017 and Mar 21, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionMar 21, 2017Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SYNTHES EVALUATION EQUIPMENT HAS A LAMINA FINDER FOR DUAL-OPENING HOOKS IN WHICH THE SHAFT COMES APART FROM THE HANDLE. THE ISSUE WAS IDENTIFIED DURING INSPECTION ACTIVITIES OF THE EVALUATION SET. THERE WERE NO PATIENT INVOLVEMENT AND NO PROCEDURE. THIS COMPLAINT INVOLVES ONE DEVICE. WHEN THE DEVICE WAS RECEIVED, IT WAS NOTED THE ITEM IS BROKEN AND MULTIPLE FRAGMENTS WERE IDENTIFIED. THE TANG OF THE SHAFT HAD COME FREE OF HANDLE. THE MAIN BODY WAS SEPARATED. IT WAS REPORTED THIS OCCURRED SOMETIME IN TRANSIT ON THE WAY TO THE MANUFACTURER FOR EVALUATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6421400 ↗