GAMMA 3120-1180SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540375025), received between Jun 26, 2019 and Sep 1, 2026 — 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.

• InjurySep 1, 2026Fracture

  ANSM reported that:Date of occurrence: (b)(6) 2026.Description of the incident: Implantation of a Gamma 3 nail on (b)(6) 2025, for a left femoral pertrochanteric fracture that had been progressing for one month and was complicated by a consolidated metastatic lesion from prostate cancer. (b)(6) 2026: Removal of the gamma nail, following the diagnosis of a left pertrochanteric pseudarthrosis resulting from radiation therapy to the metastases of the lesser trochanter, with fracture of a gamma nail implanted in (b)(6) 2025.Patient¿s current status: Revision surgery with removal of the nail and implantation of a total hip prosthesis with dual mobility.Actions taken at the healthcare facility for the patient¿s care: Removal of the nail on (b)(6) 2026."

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 50547353 ↗
• InjuryNov 7, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT WAS COMMITTED IN THE HOSPITAL FOR A RUPTURE OF THE OSTHEOSYNTHESIS MATERIAL IN THE LEFT HIP THAT WAS INITIALLY IMPLANTED IN (B)(6) 2022, SPECIFICALLY A TITANIUM NAIL.

  Patient problems: Failure of Implant

  MAUDE report 15749508 ↗
• InjuryMay 11, 2022Break; Fracture; Break; Fracture

  IT HAS BEEN REPORTED THAT THE NAIL WAS BROKEN AND THE PATIENT REQUIRED A REVISION SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 14354172 ↗
• MalfunctionNov 19, 2021Mechanical Jam; Mechanical Jam

  CUSTOMER REPORTED THE FOLLOWING ISSUE REGARDING A GAMMA NAIL REF. (B)(4), LOT K05CC65 AND THE ANCILLARY MATERIAL NECESSARY FOR ITS INSTALLATION (NAIL, TARGET DEVICE, BOLT): "DURING AN OPERATION ON (B)(6) 2021, THE MATERIAL WAS FITTED WITHOUT ANY PROBLEMS UNTIL THE NAIL HAD TO BE REMOVED FROM THE TARGET DEVICE TO COMPLETE THE OPERATION: IT WAS IMPOSSIBLE TO UNSCREW. THE CONSEQUENCES WERE A DOUBLING OF THE OPERATION TIME DUE TO THE NEED TO REMOVE EVERYTHING TO START THE WHOLE OPERATION AGAIN, AND THE NEED TO USE ANOTHER ANCILLARY AND ANOTHER NAIL LESS ADAPTED TO THE PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12849558 ↗
• InjuryJun 26, 2019Break

  PHARMACIST REPORTED THAT A GAMMA 3 NAIL, AFTER IMPLANTATION IN A PATIENT ON (B)(6) 2019, BROKE AT THE CERVICAL SCREW. FRACTURE OF THE GREATER TROCHANTER OCCURRED. MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE BROKEN NAIL. PROSTHETIC HIP WAS IMPLANTED DURING RECOVERY SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 8735323 ↗