GAMMA 3425-3400SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540406682), received between Jan 11, 2024 and Jan 11, 2024 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PATIENT HAD BROKEN HER SUBTROCHANTER WHILST SKIING. IN AUSTRIA SHE GOT AN TFNA. THE TFNA WAS BROKEN AND REPLACED BY A GAMMA3 ON (B)(6) 2023. ALSO THIS GAMMA3 BROKE, AT THE LAG SCREW AND LOCKING SCREW ON (B)(6) 2023. REVISION WAS ON (B)(6)2023. THE PATIENT FELT THE NAIL BREAKING AND HAD ACUTE PAIN. SHE WAS WALKING IN A STORE WHEN IT HAPPENED. THE GAMMA WAS REMOVED. THERE WAS 2 CM BONE REMOVED AT THE FRACTURE SITE AND REPLACED BY A T2ALPHA RECON NAIL. ALSO THE GAP WAS FILLED WITH BONE CEMENT. (CEREMENT).

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

  MAUDE report 18491939 ↗