GAMMA 3425-3360SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540406668), received between Jan 2, 2019 and Jul 27, 2020 — 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 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.

• InjuryJul 27, 2020Fracture; Fracture

  AS REPORTED: "ON THE (B)(6) 2020 THE PATIENT FALLS AND GETS A LONG GAMMA3 NAIL DUE TO A SUBTROCHANTERIC FRACTURE. THE PATIENT COMES TO A XRAY CONTROL ON THE (B)(6) BECAUSE OF PAIN. THE PATIENT DID NOT HEAL, AND IN RETROSPECT THE SURGEON CAN SEE ON THE X-RAYS, THAT THE NAIL HAD GIVEN IN ON PT CONTROL (B)(6) 2020. THE PATIENT'S PAIN GOT WORSE AND THE NAIL GAVE IN. THERE WERE LACK OF HEALING. ON THE (B)(6) THE PATIENT GOT A REOPERATION WITH EXCHANGE OF NAIL, AND GRAFTING. OUTCOME IS STILL UNCERTAIN."

  Patient problems: Implant Pain; Injury; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 10329690 ↗
• InjuryJan 2, 2019Break

  IT WAS REPORTED THAT THE GAMMA NAIL IN THE PATIENT'S RIGHT FEMUR HAS BROKEN. LOCATION OF IMPLANT BREAKAGE UNKNOWN AT TIME OF REPORT, BUT SURGEON REPORTED FROM A PREVIOUS REVISION THAT PATIENT HAS A HISTORY OF OSTEOPOROSIS. PATIENT IS SCHEDULED FOR REVISION AT THE END OF (B)(6).

  Patient problems: Failure of Implant

  MAUDE report 8207884 ↗