SYMPHONY 3010-19-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034561653), received between Jan 9, 2024 and Sep 9, 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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 9, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THAT ON AN UNKNOWN DATE THE SLEEVE GOT STUCK OVER THE SCREW. TO REMOVE THE SCREW, IT WAS NEEDED TO BREAK THE SLEEVE. IN THE PROCESS OF BREAKING THE SLEEVES, THE DRIVER BROKE AND THE THREADED TIP GOT STUCK IN THE SHAFT OF THE SCREW. BOTH ARE NOW BROKEN. PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) SYMPHONY NAV DRIVER - SLEEVE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20177322 ↗
• MalfunctionJan 9, 2024Break; Break

  IT WAS REPORTED THAT ON UNKNOWN EVENT DATE DEVICE BROKE IN CASE. NO PATIENT CONSEQUENCES REPORTED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY OR NOT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) SYMPHONY NAV DRIVER - SLEEVE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18476155 ↗