GAMMA 3525-0320SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540375728), received between May 11, 2018 and Oct 31, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (5 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.

• InjuryOct 31, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "DUE TO POOR REDUCTION AT THE PRIMARY SURGERY ON (B)(6) 2023 A NON-UNION WAS OCCURRED AND THE NAIL FRACTURE WAS OCCURRED. REVISION SURGERY IS SCHEDULED FOR REPLACEMENT OF THE GAMMA NAIL."

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

  MAUDE report 18044280 ↗
• InjuryJun 19, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A GAMMA NAIL WAS BROKEN DUE TO PSEUDARTHROSIS POSTOPERATIVELY.

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

  MAUDE report 17151413 ↗
• InjuryJun 22, 2021Fracture; Fracture

  IT WAS REPORTED THE LONG GAMMA NAIL BROKE AS A RESULT OF CONTINUOUS STRESS CONCENTRATION ON THE NAIL DUE TO POOR REDUCTION. A REPLACEMENT OPERATION WAS CARRIED OUT ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 12045887 ↗
• InjuryJun 11, 2020Fracture; Fracture

  IT WAS REPORTED: A (B)(6) YEAR OLD, MALE PATIENT WAS DISCHARGED FROM THE HOSPITAL ONE WEEK AFTER ORIF PROCEDURE WITH GAMMA NAIL ON (B)(6) 2020. AT THAT TIME, HE WAS ABLE TO WALK NORMALLY USING CRUTCHES, AND FOLLOWED UP WITH ANOTHER HOSPITAL. HOWEVER; ON (B)(6) THE PATIENT WAS RETURNED FROM ANOTHER HOSPITAL TO THE HOSPITAL WHERE HE HAD SURGERY DUE TO A POSSIBLE NAIL BREAKAGE. HE WAS VERY HEAVY ((B)(6)) AND AT THE TIME OF THE INITIAL SURGERY THE SURGEON ATTEMPTED TO WRAP THE FEMUR WITH A CABLE, BUT IT COULD NOT WRAP WELL AND THERE WAS NO BONE CONTACT INSIDE. SO PROBABLY, ALL THE NAILS WERE LOADED AND BROKE. REVISION IS SCHEDULED ON (B)(6).

  Patient problems: Failure of Implant; Injury

  MAUDE report 10144817 ↗
• InjuryMay 11, 2018Fracture

  ON (B)(6) 2016, LONG GAMMA NAIL WAS IMPLANTED AS A TREATMENT FOR TROCHANTER FRACTURE. PARTIAL LOAD WAS STARTED 1 WEEKS LATER AFTER SURGERY AND TOTAL LOAD STARTED AT 9 WEEKS. FELT SOMETHING STRANGE IN (B)(6) 2018, VISITED THE HOSPITAL ON (B)(6) 2018. FRACTURE OF THE PROXIMAL PART OF THE NAIL WAS DISCOVERED COMPARED WITH RADIOGRAPHING. IT WAS REPLACED ON (B)(6) WITH A REPLACEMENT OF LONG GAMMA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7507091 ↗