GAMMA 3430-1340SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252273950), received between Nov 19, 2020 and Apr 12, 2023 — classified as 1 death, 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 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 12, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "IT WAS REPORTED THAT THE PATIENT'S RIGHT FEMUR WAS REVISED DUE TO NON-UNION AND A BROKEN NAIL (NAIL BROKE AT THE JUNCTION OF THE NAIL AND THE LAG SCREW). ALL HARDWARE WAS REMOVED AND A COMPETITOR HIP WAS IMPLANTED. REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE".

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

  MAUDE report 16728298 ↗
• DeathNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "I WAS MADE AWARE BY ANOTHER CONSULTANT OF AN EVENT THAT OCCURRED - WHERE A GAMMA NAIL WAS IMPLANTED IN THE PATIENT, HOWEVER THE TIP-APEX DISTANCE OF THE LAG SCREW WAS WRONG SO THE SCREW CUT OUT AND NEEDED REVISION, PATIENT STARTED LOSING A LARGE AMOUNT OF BLOOD AND LATER WAS PRONOUNCED DECEASED IN ICU. THE CASE AND CORRESPONDING SURGEON IS NOW UNDER INVESTIGATION."

  Patient problems: Exsanguination; Perforation

  MAUDE report 10871616 ↗