NA 702851Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540413857), received between Aug 13, 2019 and Aug 13, 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.

• MalfunctionAug 13, 2019Break; Use of Device Problem; Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING A PRIMARY PROCEDURE FOR PELVIC PLATING, THE SCREWDRIVER WAS FOUND TO BE STRIPPED AND WOULDN'T ENGAGE WITH THE SCREW PROPERLY. THE TRAY HAS A SECOND SCREWDRIVER BUT THE PROCEDURE REQUIRED TWO DIFFERENT DRIVERS TO BE USED FOR DIFFERENT PARTS OF THE CASE. WHILE THE SURGEON USED THE SECOND DRIVER FROM THE FIRST SET, THE REP WAS ABLE TO OBTAIN A NEW DRIVER FROM A DIFFERENT SET SO THAT THE SURGERY COULD BE COMPLETED SUCCESSFULLY WITH NO DELAY. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8890715 ↗