USS 03.607.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034712871), received between Dec 23, 2019 and Dec 23, 2019 — 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.

• MalfunctionDec 23, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING LOAN KIT INSPECTION IT WAS NOTICED THAT THE ONE OF THE FLEXIBLE JAWS OF HOLDING SLEEVE FOR USS POLYAXIAL HAS SNAPPED OFF. NO FURTHER INFORMATION IS REPORTED. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE FOR USS POLYAXIAL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9512288 ↗