GAMMA 3425-0360SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540375353), received between Dec 18, 2018 and Dec 8, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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.

• InjuryDec 8, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DUE TO THE NAIL AND CONDYLE SCREW BREAKING, THEY WERE REMOVED AND REPLACED TO GMRS.

  Patient problems: Failure of Implant

  MAUDE report 18297559 ↗
• InjuryDec 20, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A GAMMA NAIL BROKE APPROX. 3 MONTHS POST SURGERY, RESULTING IN A REVISION SURGERY.

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

  MAUDE report 16014667 ↗
• MalfunctionAug 5, 2020Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  AS REPORTED: "THE PHYSICIAN FOUND PLASTIC POWDER ON THE DEVICE, WHEN THE PACKAGING WAS OPENED." ADDITIONALLY REPORTED: - "THE PHYSICIAN CLEANED POWDER ON THE DEVICE AND USED IT." - "THE SPONGE [FOAM OF THE PACKAGING] WAS WORN"

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10370513 ↗
• InjuryJun 12, 2020Fracture; Fracture

  AS REPORTED: A (B)(6) YEAR OLD MALE PATIENT HAD OPERATION WITH GAMMA NAIL FOR FEMORAL TROCHANTERIC FRACTURE ON (B)(6) 2019 AND WAS DISCHARGED WITHOUT POSTOPERATIVE PROBLEMS. THERE WAS NO PROBLEM WITH X-RAY AFTER 3 MONTHS. HOWEVER, WHEN HE REVISITED THE HOSPITAL ON (B)(6) 2020 AND TOOK AN X-RAY, IT WAS DISCOVERED THAT THE NAIL HAD BROKEN. IT SEEMS THAT THE NAIL WAS OVERLOADED DUE TO THE FALSE JOINT. REVISION (THA) IS SCHEDULED ON (B)(6) 2020.

  Patient problems: Injury; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10150807 ↗
• InjuryDec 18, 2018Break

  PATIENT HAD RIGHT GAMMA NAIL PUT IN (B)(6) AT ANOTHER HOSPITAL FOR A LEFT FEMUR FRACTURE AND SUBSEQUENTLY BROKE THE DISTAL END OF FEMUR. PATIENT HAD FRACTURE AND NEEDED REOPERATION.

  Patient problems: Bone Fracture(s)

  MAUDE report 8176744 ↗