GAMMA 3425-0280SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540375315), received between Mar 29, 2018 and Sep 20, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2024Break; Fracture; Device Damaged by Another Device; Break; Fracture; Device Damaged by Another Device

  IT WAS REPORTED, WHEN THE PATIENT VISITED THE HOSPITAL BECAUSE OF THE PROXIMAL HUMERUS FRACTURE, HE ALSO HAD PAIN IN HIS FEMUR, WHERE THE SURGERY WAS PERFORMED AT ANOTHER HOSPITAL A YEAR AND A HALF AGO. THUS, X-RAY WAS TAKEN AND IT REVEALED PSEUDOARTICULAR OF THE FEMUR AND THE GAMMA3 NAIL FRACTURE AT THE LAG SCREW HOLE PART. THE GAMMA3 NAIL WILL BE REMOVED AT THE SAME TIME AS THE SURGERY FOR THE PROXIMAL HUMERUS FRACTURE ON (B)(6) 2024.

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

  MAUDE report 20269627 ↗
• InjuryAug 16, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A NAIL BROKE, RESULTING IN BHA REVISION SURGERY. THE BREAK WAS NOTICED DURING A REGULAR CHECKUP AND IT WAS ALSO NOTED THAT THERE WAS DELAYED UNION OF THE FRACTURE.

  Patient problems: Failure of Implant; Impaired Healing

  MAUDE report 15237939 ↗
• InjuryMar 29, 2018Material Perforation; Positioning Problem

  THE PATIENT UNDERWENT GAMMA3 SURGERY ON (B)(6) 2017. WHEN THE PATIENT VISITED A HOSPITAL WITH ANOTHER DISEASE, SHORTENING OF RIGHT LEG WAS POINTED OUT, AND THEN TRANSFERRED TO THE HOSPITAL THAT THE INITIAL SURGERY WAS PERFORMED. X-RAY SHOWED A FEMORAL HEAD PERFORATION BUT THE PATIENT DID NOT FEEL ANY PAIN DUE TO SCHIZOPHRENIA, THIS WAS ONE OF THE REASON WHY THE PERFORATION WAS ADVANCED IN THE SURGEON'S OPINION. REVISION SURGERY WAS PERFORMED ON (B)(6) 2018, THE LAG SCREW WHICH REACHED INTESTINAL TRACT WAS REMOVED WITH LAPAROSCOPIC SURGERY, AND THE GAMMA3 NAIL WAS REMOVED SUBSEQUENTLY. THERE WERE NO DAMAGES NOTED TO THE LAG SCREW BY A SET SCREW. IN THE SURGEON'S OPINION, THE MAIN REASON OF THE PERFORATION WAS THE SET SCREW WAS NOT REACHED TO THE LAG SCREW. FEMORAL HEAD PERFORATION, REVISION.

  Patient problems: No Code Available

  MAUDE report 7383206 ↗