GAMMA 3420-0300SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540375193), received between Oct 27, 2020 and Jun 23, 2025 — classified as 2 injuries.

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

• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "A PATIENT WITH A GAMMA3 LONG NAIL FELL AND SUFFERED A PERI-IMPLANT FRACTURE.ON (B)(6) 2025, THE GAMMA 3 NAIL WAS REMOVED AND OSTEOSYNTHESIS WAS PERFORMED."

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 22311101 ↗
• InjuryOct 27, 2020Fracture; Fracture

  AS REPORTED: "ON (B)(6) 2019, A PATIENT UNDERWENT THE INITIAL OPERATION DUE TO SUBTROCHANTERIC FRACTURE OF THE FEMUR. ON (B)(6) 2020, SHE IS SCHEDULED TO HAVE REVISION SURGERY, BECAUSE AN ATYPICAL FRACTURE CAUSED BY POOR BONE FUSION AND A NONUNION OCCURRED. THE REPORTING SR WAS CHECKING THE PROGRESS TO SEE IF IT WOULD HEAL, BUT THE BONES DID NOT HEAL AND THE NAIL BROKE." NAIL BREAKAGE DUE TO NONUNION.

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

  MAUDE report 10743987 ↗