N/A 302022012Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034558158), received between Dec 20, 2021 and Jun 9, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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. 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.

• MalfunctionJun 9, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM DEPUYSYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT PRIOR TO SURGERY TWO SYMPHONY MDT NAVIGATION RINGS BURRED DURING ATTACHMENT. THIS REPORT IS FOR A SYMPHONY MDT NAVIGATION RING. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14645496 ↗
• MalfunctionJun 9, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PRIOR TO SURGERY TWO (2) SYMPHONY MDT NAVIGATION RINGS BURRED DURING ATTACHMENT. THIS REPORT IS FOR A SYMPHONY MDT NAVIGATION RING. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14645440 ↗
• InjuryDec 20, 2021Break; Entrapment of Device; Mechanical Jam; Break; Entrapment of Device; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A NAVIGATED SYMPHONY SURGERY, THE SCREW WHICH CONNECTS THE UNIVERSAL NAVIGATION ADAPTOR SET (UNAS) RING WITH THE STERN BROKE. THE SCREW JAMMED AND BROKE WHILE TRYING TO UNSCREW IT. IT WAS NOTED THAT FRAGMENTS WERE GENERATED WHEN THE SCREW BROKE AND THOSE FRAGMENTS WERE RETAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A UNIVERSAL NAVIGATION ADAPTOR SET (UNAS) RING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13046475 ↗