GAMMA 3425-3420SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540406699), received between Jun 16, 2021 and Oct 29, 2024 — classified as 2 injuries.

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

• InjuryOct 29, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "THE PATIENT UNDERWENT SURGERY IN (B)(6) 2023, BUT A REVISION SURGERY WAS REQUIRED IN (B)(6) 2024 AS A RESULT OF A FRACTURE OF THE GAMMA NAIL."

  Patient problems: Failure of Implant

  MAUDE report 20557954 ↗
• InjuryJun 16, 2021Fracture; Fracture

  IT WAS REPORTED THE PATIENT RECEIVED THE NAIL ON 4/12. PATIENT WAS PERFORMING PT GOING FROM SEATED TO STANDING POSITION AND THE NAIL BROKE; PER THE PATIENT THEY DID NOT FALL. REPLACEMENT NAIL WAS THE SMITH AND NEPHEW INTERTAN. ACCORDING TO THE PHYSICIAN, THE PATIENT WAS COMPLIANT. THE PATIENT HAD A HIGH BMI BETWEEN 45-50. OUTSIDE OF THAT CIRCUMSTANCE, THERE WERE NO OTHER OUTSTANDING FACTORS. FRACTURE WAS A 31-A2.

  Patient problems: Failure of Implant

  MAUDE report 12010045 ↗