TRIO + 48905022Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327273144), received between Mar 9, 2016 and Mar 9, 2016 — 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.

• MalfunctionMar 9, 2016Fracture; Material Integrity Problem; Break; Detachment Of Device Component; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT THE SURGEON ACCIDENTALLY GRABBED THE SCREWDRIVER INSTEAD OF THE SOLID 3.5MM HEX HEAD TO REMOVE A SCREW AND THE COLLET TIP BROKE OFF INTO THE SCREW. THE BROKEN PIECES WERE REMOVED SUCCESSFULLY AND THERE WAS NO CONSEQUENCES TO THE PATIENT. THE SURGERY WAS NOT DELAYED BECAUSE THE SALES REP HAD THE SURGICAL TECH HAND HIM THE CORRECT DRIVER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 5489938 ↗