GAMMA 3525-0440SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540375780), received between Sep 8, 2020 and Sep 8, 2020 — classified as 1 injury.

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

• InjurySep 8, 2020Fracture; Fracture

  AS REPORTED IN MEDWATCH (B)(4): "MD'S DESCRIPTION OF THE INCIDENT: [LEFT] GAMMA3 NAIL THAT BROKE THROUGH PROXIMAL SCREW APERTURE AT 6 WEEKS. NAIL WAS NOTED TO BE NOTCHED MOST LIKELY MOST LIKELY AT TIME OF INSERTION. NAIL WAS...FOUND TO BE BROKEN IN X-RAY 1.5 MONTHS LATER." PATIENT WAS REVISED TO ANOTHER NAIL. ADDITIONALLY REPORTED: "PATIENT WAS WALKING ON MEMORIAL DAY, WHEN HE FELT A SUDDEN INCREASE IN PAIN IN HIS LEFT HIP."

  Patient problems: Failure of Implant; Implant Pain; Injury

  MAUDE report 10504968 ↗