GAMMA 3530-0360SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540375872), received between Sep 9, 2015 and Sep 9, 2015 — 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.

• InjurySep 9, 2015Break

  IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT UNDERWENT THE SURGERY WITH THE G3 LONG NAIL. ON (B)(6) 2015, THE PATIENT FELT THE PAIN IN THE HIP JOINT. AFTERWARDS, ON (B)(6) 2015, THE SURGEON CONFIRMED X-RAY. AND HE FOUND THAT THE NAIL WAS BROKEN. THE FRACTURE PART WAS NON-UNION. THEREFORE, THE SURGEON PERFORMED THE REVISION SURGERY BY THE COMPETITOR DHS ON (B)(6) 2015.

  Patient problems: Pain

  MAUDE report 5064753 ↗