TRIO 48906075Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327273328), received between May 11, 2016 and Sep 5, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT THE HEX SOCKET BROKE DURING FINAL TIGHTENING. ALL BROKEN FRAGMENTS WERE RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE INSTRUMENT, WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7847928 ↗
• MalfunctionAug 14, 2018Break; Fracture; Fracture

  IT IS REPORTED THAT THE TIP HEX SOCKET OF A TORQUE WRENCH BROKE OFF IN A CONNECTOR WHEN FINAL TIGHTENING. NO ADVERSE CONSEQUENCES TO THE PATIENT IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7782883 ↗
• MalfunctionFeb 9, 2018Break; Detachment Of Device Component; Fracture; Fracture

  WHILE PERFORMING FINAL TIGHTENING, THE 3.5 HEX SOCKET BROKE OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACKUP ATTACHMENT. THERE WERE NO ADVERSE HEALTH CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7259579 ↗
• MalfunctionMay 25, 2016Break

  IT WAS REPORTED THAT THE HEX ATTACHMENT FOR THE TORQUE DRIVER BROKE WHILE TORQUING THE CONNECTORS, HAD ANOTHER HEX ATTACHMENT THAT WAS USED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5679620 ↗
• MalfunctionMay 11, 2016Break; Sticking; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT; TORQUE WRENCH TIP BROKE WHILE FINAL TIGHTENING. TIP WAS THEN STUCK IN CONNECTOR AND HAD TO BURR IT OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5648149 ↗