Tornier Latitude 9030375Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00846832019991), received between May 3, 2021 and Mar 1, 2022 — classified as 3 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. 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.

• MalfunctionMar 1, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OF IN THE SCREW HEAD AND REMAINED IN THE PATIENT. THIS CAUSED A 2 MINUTE DELAY IN SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13636174 ↗
• MalfunctionAug 16, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A REVISION SURGERY THE TIP OF THE DRIVER BROKE OFF TRYING TO LOOSEN THE ULNA CAP OFF OF THE LOOSE ULNA COMPONENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12328279 ↗
• MalfunctionMay 3, 2021Break; Break

  IT WAS REPORTED THE DRIVER WAS BEING USED WITH A 10NM TORQUE HANDLE AND THAT THE TIP OF THE DRIVER BROKE OFF IN THE HEAD OF THE SCREW AND WAS COLD WELDED TO THE SCREW HEAD. THE TIP WAS NOT ABLE TO BE RETRIEVED FROM THE PATIENT. THE SURGEON PROCEEDED TO FOLD THE TAB OVER WITH THE PUNCH ON THE ULNAR CAP. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11767762 ↗