GAMMA 3425-1280SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613252273790), received between Nov 6, 2020 and Jul 30, 2024 — classified as 3 injuries, 1 malfunction.

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

• InjuryJul 30, 2024Break; Fracture; Device Damaged by Another Device; Break; Fracture; Device Damaged by Another Device

  AS REPORTED: ''THE CUSTOMER REPORTS A BROKEN GAMMA NAIL, THE REVISION SURGERY IS PLANNED FOR (B)(6) 2024.''

  Patient problems: Failure of Implant

  MAUDE report 19860063 ↗
• InjuryNov 13, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "BREAKAGE OF THE INTRAMEDULLARY NAIL USED FOR FEMUR FRACTURE SURGERY. THE PATIENT REQUIRED REVISION SURGERY." UPDATE: THE PATIENT COMPLAINED PAIN ON 27/07/23.

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

  MAUDE report 18117949 ↗
• MalfunctionMay 24, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED: "THE SURGERY WAS ALMOST COMPLETE WHEN THE AIMING DEVICE WAS TO BE REMOVED, IT WAS NOT DETACHABLE. THE AIMING DEVICE CANNOT BE REMOVED FROM THE LONG GAMMA NAIL. THERE WAS A QUASI COLD CONNECTION BETWEEN THE IMPLANT AND THE INSERTION AID. CONSEQUENCE: REMOVAL OF THE ALREADY FULLY IMPLANTED NAIL INCL. FEMORAL NECK SCREW AND DISTAL LOCKING AND RE-IMPLANTATION OF A NEW NAIL. THE PROCEDURE WAS DELAYED BY 1H WHICH LEAD TO HIGHER BLOOD LOSS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14487171 ↗
• InjuryNov 6, 2020Fracture; Fracture

  AS REPORTED: "IN (B)(6) 2020, THE PATIENT SUFFERED A SUBTROCHANTERIC FEMUR FRACTURE ON THE RIGHT SIDE, WHICH WAS SURGICALLY TREATED WITH A GAMMA NAIL FROM STRYKER. THE PATIENT WAS THEN TRANSFERRED FROM THE (B)(6). THERE EXISTED PAIN IN THE RIGHT FEMUR FOR 5 DAYS. NATIV RADIOLOGY SHOWS A BROKEN GAMMA- NAIL ON THE RIGHT. TRAUMA IS NOT MEMORABLE. AS A CONSEQUENCE A REVISION SURGERY HAD TO BE PERFORMED. COMPLEX REMOVAL OF THE GAMMA NAIL AND RE-OSTEOSYNTHESIS.".

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 10805294 ↗