T2 1896-5045Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613153179412), received between Sep 13, 2023 and Sep 13, 2023 — classified as 1 injury.

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.

• InjurySep 13, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "Z.N. TREATMENT OF A SUBTROCHANTERIC FEMUR FRACTURE WITH A LONG GAMMA NAIL (11MM X 360MM X 125°; FEMORAL NECK SCREW 115MM). POSTOPERATIVE FOLLOW-UP WITH PARTIAL WEIGHT BEARING FOR 8 WEEKS. PRESENTATION VIA CENTRAL EMERGENCY DEPARTMENT AFTER FALL WITH PAIN IN THE HIP. RADIOLOGICALLY SHOWED FRACTURE OF BOTH DISTAL SCREWS AS WELL AS THE GAMMA NAIL IN THE AREA OF THE FEMORAL NECK SCREW. REVISION SURGERY WAS PERFORMED WITH REMOVAL OF THE FRACTURED GAMMA NAIL AND RE-OSTEOSYNTHESIS WITH A FEMORAL NAIL."

  Patient problems: Failure of Implant; Fall; Implant Pain

  MAUDE report 17738237 ↗