GAMMA 3425-3340SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540406651), received between Jun 19, 2020 and Jun 9, 2023 — classified as 2 injuries.

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.

• InjuryJun 9, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "INCREASING PAIN OF THE PATIENT IN THE HIP WITHOUT TRAUMA. X-RAY SHOWED NAIL FRACTURE. THE DEVICE WAS REVISED".

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 17097517 ↗
• InjuryJun 19, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS REPORTED: (B)(6) HOSPITAL WAS DOING A GAMMA NAIL AND INSERTED A RIGHT NAIL INTO A LEFT FEMUR. DUE TO THE BOW IN THE NAIL, THE NAIL FRACTURED THE DISTAL ANTERIOR CORTEX OF THE PT'S FEMUR BUSTING OUT THROUGH THE BONE. NOT KNOWING WHAT CAUSED THIS TO OCCUR, THE SURGEON OPENED A LONGER NAIL TO TRY AND BY-PASS THIS NEWLY CREATED FRACTURE BUT THIS TOO WAS A RIGHT (WRONG SIDED) NAIL AND THE SAME ISSUE OCCURRED WITH THE NAIL GOING THROUGH THE SAME DISTAL ANTERIOR FRACTURE. IT WAS AT THIS TIME THEY HAD REALISED THE WRONG SIDED NAILS WERE USED BOTH TIMES. IT WAS NOT LONG AFTER THIS I ARRIVED AT THE HOSPITAL. SURGICAL DELAY OF APPROX 60 MINUTES.

  Patient problems: Bone Fracture(s); Iatrogenic Source

  MAUDE report 10176359 ↗