T2 1843-1238SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540412294), received between Jun 9, 2021 and Jun 9, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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.

• InjuryJun 9, 2021Fracture; Fracture

  IT WAS REPORTED THE PATIENT HAD A L SUBTROCHANTERIC HIP FRACTURE FIXED WITH A 12X380MM RECONSTRUCTION NAIL ON (B)(6) 2020. PATIENT WENT ON TO NONUNION AND A BROKEN IMPLANT ON (B)(6) 2021. THE IMPLANT BROKE AT THE LEVEL OF THE INFERIOR RECON SCREW. NAIL WAS REMOVED ON (B)(6) 2021 AND REVISED WITH A SMITH AND NEPHEW INTERTAN.

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 11967449 ↗