GAMMA 3425-0320SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540375339), received between Jul 9, 2020 and Apr 23, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2025Break; Fracture; Device Damaged by Another Device; Break; Fracture; Device Damaged by Another Device

  AS REPORTED: "THE BREAKAGE OF THE GAMMA 3 LONG NAIL WAS DISCOVERED DURING A PERIODIC VISIT TO THE HOSPITAL ON MARCH 28. REVISION SURGERY NEEDED.".

  Patient problems: Impaired Healing; Insufficient Information

  MAUDE report 21894321 ↗
• InjuryDec 27, 2024Use of Device Problem; Use of Device Problem

  AS REPORTED: "WE HAD AN INCIDENT YESTERDAY AT (B)(6). WE WERE USING A RIGHT GAMMA NAIL AND THE GAMMA NAIL IS LABELED AS A 10 BY 320 BY 125 FOR THE RIGHT SIDE. UNFORTUNATELY, WE PUT THE NAIL IN AND REALIZED THAT IT WAS GOING TO BE TOO SHORT, SO THEY PULLED THE NAIL BACK OUT. WHEN WE MEASURED THE NAIL WITH A RULER, IT WAS MEASURED CLOSER TO 305, WHICH IS MUCH SHORTER THAN THE 320 THAT IT WAS LABELED AS THE NAIL, THE STICKER AND THE BOX ALL SAID 320, BUT THE ACTUAL LENGTH OF THE NAIL IS SHORTER."

  Patient problems: Insufficient Information

  MAUDE report 21030132 ↗
• InjuryJan 11, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "ORIF FOR RIGHT FEMORAL TROCHANTERIC FRACTURE WAS PERFORMED. ON (B)(6) 2023, WHICH WAS ABOUT 2 YEARS AFTER THE FIRST SURGERY, IT WAS FOUND THAT THE GAMMA3 LONG NAIL WAS BROKEN AT THE SITE OF LAG SCREW HOLE. THE REVISION SURGERY TO REPLACE THE NAIL WAS PERFORMED ON (B)(6) 2023."

  Patient problems: Failure of Implant

  MAUDE report 18494369 ↗
• InjurySep 22, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "BREAST CANCER PATIENT, CASE OF META. PRIMARY SURGERY WITH LONG GAMMA ON (B)(6) 2021. POSTOPERATIVELY, RADIOTHERAPY TO THE AFFECTED AREA. CURRENTLY TUMOR MARKER 0. AS OF (B)(6) 2023, THERE IS NO FUSION AND THE FRACTURE AREA APPEARS TO BE SLIGHTLY MORE OPEN THAN IT WAS IMMEDIATELY AFTER SURGERY. NAIL FRACTURE WAS CONFIRMED ON (B)(6) 2023.

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

  MAUDE report 17799760 ↗
• InjuryJul 9, 2020Fracture; Fracture

  IT WAS REPORTED: A NAIL BREAKAGE OCCURRED. SINCE IT HAS BEEN A WHILE SINCE IT WAS IMPLANTED, IT IS THOUGHT TO BE A BREAKAGE DUE TO METAL FATIGUE. REVISION SURGERY OCCURRED AS A RESULT.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10253289 ↗