T2 1830-0727SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540201331), received between Apr 1, 2021 and Apr 1, 2021 — 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 18, 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.

• MalfunctionApr 1, 2021Break; Fracture; Break; Fracture

  AS REPORTED: "PRIMARY PROCEDURE, LEFT HUMERAL NAIL. IT WAS REPORTED THAT AFTER THE LOCKING SCREW WAS IMPLANTED AT THE DISTAL END OF THE NAIL, THE SURGEON BACK-SLAPPED THE CONSTRUCT TO COMPRESS A FRACTURE. THE DISTAL END OF THE NAIL BROKE AT THE JUNCTION WITH THE LOCKING SCREW. THE SCREW WAS REMOVED AND ANOTHER LOCKING SCREW WAS IMPLANTED ABOVE THE PREVIOUS IMPLANT SITE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 1-2 MINUTES. ADDITIONAL INFO RECEIVED ON 03/09/2021 DISTAL LOCKING SCREW DID NOT BREAK, ONLY DISTAL END OF NAIL. DISTAL LOCKING SCREW WAS REMOVED AND REPLACED WITH ANOTHER LOCKING SCREW THAT LOCKED THE NAIL IN THE MOST PROXIMAL HOLE OF THE DISTAL LOCKING OPTIONS IN. THE BROKEN TIP AS WELL AS THE REST OF THE NAIL AND LOCKING SCREWS REMAINS IN PATIENT TO FIX THEIR MID SHAFT HUMERUS FRACTURE. THE SMALL UNIVERSAL EXTRACTION ROD THAT IS DEDICATED TO THE T2 HUMERAL SYSTEM WAS USED TO BACK-SLAP. THE SCREW WAS NOT BROKEN, THE TIP OF THE NAIL AT THE SCREW HOLE JUNCTION WAS."

  Patient problems: Foreign Body In Patient

  MAUDE report 11604256 ↗