GAMMA 3525-0360SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540375742), received between Jul 12, 2019 and Oct 15, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Fracture; Fracture

  AS REPORTED: "IMPLANT FRACTURE AFTER NON-CONSOLIDATED FRACTURE, IMPLANTATION (B)(6) 2023. EVIDENCE OF A NAIL FRACTURE, AT THE LEVEL OF THE FEMORAL NECK SCREW, IN PSEUDARTHROSIS AFTER PROXIMAL FEMUR FRACTURE AS A RESULT OF A TRAFFIC ACCIDENT WITH IMPLANTATION OF A LONG GAMMA NAIL ON (B)(6) 2023. ADIPOSITY PER MAGNA 160KG AT 1.6M. PAIN OVER THE AFFECTED HIP SINCE THE BEGINNING OF AUGUST. EXPLANTATION OF THE BROKEN IMPLANT, IMPLANTATION OF A NEW IMPLANT."

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

  MAUDE report 23300238 ↗
• InjuryJul 8, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A CASE OF SUBCONDYLAR FRACTURE WAS TREATED WITH GAMMA 3 NAILS, BUT A PSEUDOARTHROSIS OCCURRED AND THE NAILS AND SCREWS WERE BROKEN OFF. THE PATIENT WAS REPLACED WITH A NAIL FROM ANOTHER COMPANY ON JUNE 13TH. NAIL HAS A BROKEN LAG SCREW HOLE SECTION, AND TWO LOCKING SCREWS WERE ALSO BROKEN.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 22444994 ↗
• InjuryDec 12, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "POSTOPERATIVELY GAMMA3 LONG NAIL WAS BROKEN AND A REVISION SURGERY WAS PERFORMED. THE BROKEN PART IS THE LAG SCREW HOLE."

  Patient problems: Failure of Implant

  MAUDE report 15963396 ↗
• InjuryMar 5, 2021Fracture; Fracture

  AS REPORTED: "PATIENT FELL, GAMMA NAIL BROKE AT LAG SCREW JUNCTION." PATIENT WAS REVISED TO A GMRS PROXIMAL FEMUR WITH BIPOLAR. ADDITIONAL INFO RECEIVED FROM THE REPRESENTATIVE (B)(6) 2021: DOCTOR HAS INDICATED THAT THE ¿PATHOLOGIC FRACTURE W RADIATION, BONE NEVER HEALED, PATHOLOGIC NON-UNION¿.

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

  MAUDE report 11426288 ↗
• MalfunctionJul 1, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED: "WHEN I OPENED THE LONG GAMMA 3 NAIL AND TRIED TO SET IT, I NOTICED THAT WHITE DEBRIS HAD ADHERED TO THE NAIL. I TOOK THE ONE THAT ADHERED TO THE SURFACE, BUT IT MIGHT STILL BE IN THE NAIL. A NEW NAIL WAS OPENED AND USED. THE WHITE DEBRIS WAS THE SCRAPED OFF SPACER THAT FIXED THE NAIL. IT WAS DISCARDED."

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

  MAUDE report 10218330 ↗
• InjuryJan 14, 2020Fracture; Fracture

  PRIMARY GAMMA3 SURGERY WAS PERFORMED ON (B)(6) 2019. 7 MONTHS AFTER THE SURGERY, THE PATIENT COMPLAINED DISCOMFORT AND THE NAIL BREAKAGE AT THE LAG SCREW HOLE WAS CONFIRMED.

  Patient problems: Discomfort; Failure of Implant; Injury

  MAUDE report 9586087 ↗
• InjuryJul 12, 2019Break; Fracture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT'S LEFT FEMUR WAS REVISED DUE TO FEMORAL PERIPROSTHETIC FRACTURE, AND BREAKAGE OF THE NAIL AT THE FRACTURE SITE. PATIENT WAS REVISED TO COMPETITOR DEVICES.

  Patient problems: No Information

  MAUDE report 8784562 ↗