GAMMA 3525-0400SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540375766), received between May 18, 2023 and May 18, 2023 — 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.

• InjuryMay 18, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT: "PATIENT WITH A GAMMA3 NAIL BROKE INSIDE PATIENT. INSTALLED ON (B)(6) 2023 AND SUBSEQUENTLY BROKE (DATE UNKNOWN BUT PROBABLY A FEW DAYS BEFORE (B)(6) 2023). APPARENTLY PATIENT WAS TOLD THEY COULD WALK SOON/SOME TIME AFTER SURGERY. BROKEN NAIL REMOVED AND REPLACED WITH ANOTHER GAMMA3 NAIL ON (B)(6) 2023."

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

  MAUDE report 16953259 ↗