GAMMA 3425-1300SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252273806), received between Feb 17, 2022 and Apr 26, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 26, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "BREAKAGE OF THE NAIL. A REVISION WILL PROBABLY HAVE TO BE PERFORMED."

  Patient problems: Failure of Implant

  MAUDE report 16820690 ↗
• InjuryFeb 17, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT AFTER AN HOUR AND A QUARTER SURGICAL OSTEOSYNTHESIS OF THE RIGHT FEMUR WITH INTRAMEDULLARY NAIL DUE TO A RIGHT FEMORAL PER-SUB TROCHANTERIC FRACTURE, THE X-RAY FINDING OF THE RUPTURE OF THE DEVICE WITH THE NEED FOR HOSPITALIZATION AND REVISION SURGERY.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 13552291 ↗