GAMMA 1420-0105Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327479928), received between Feb 11, 2025 and Apr 2, 2026 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Mechanical Jam

  THE CUSTOMER REPORTED THAT : "THE GAMMA NAIL GOT STUCK IN ITS NAIL HOLDER. IT WAS IMPOSSIBLE TO UNSCREW IT. SEE ATTACHED PHOTOS. THE PROCEDURE HAD TO BE REPEATED, REMOVING THE CERVICAL AND DISTAL SCREWS AND THE NAIL, USING A NEW NAIL HOLDER AND NEW IMPLANTS. THE NAIL CANNOT BE SEPARATED FROM ITS NAIL HOLDER AND IS SENT FOR STERILIZATION MOUNTED ON THE NAIL HOLDER. THIS RESULTS IN WASTED TIME, A LONGER PROCEDURE, AND EXCESSIVE USE OF MATERIALS.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24770163 ↗
• DeathMar 25, 2026Mechanical Jam

  AS REPORTED: "UNABLE TO UNSCREW BOLT FROM THE NAIL- TRIED EVERYTHING, HAD TO REMOVE ALL IMPLANTS FROM PATIENT AND PUT IN GAMMA 3 NAIL. A GAMMA 3 11 X 180 X 125 NAIL WAS USED TO COMPLETE THE SURGERY. THE ACTUAL CASE WAS DONE WITHIN 45-60 MINS. THIS WAS THE LAST STEP (REMOVING TARGETER) UPON COMPLETION AND THIS ADDED ABOUT AN HOUR TO PROCEDURE. THIS MEANT 60 MORE MINUTES OF OPEN SURGICAL WOUNDS, REDOING THE PROCEDURE USING GAMMA3, FURTHER BLOOD LOSS (OPEN WOUNDS), HIGHER RISK OF INFECTION (PROLONGED TIME OPEN WOUNDS, OPEN IMPLANTS), AND FURTHER TIME FOR A SICK PATIENT UNDER ANESTHETIC. PATIENT HAS SINCE BEEN RE INTUBATED FOR HYPOTENSION, RESPIRATORY FAILURE AND ISCHEMIC STROKE POST OP DAY 1. PATIENT ALSO HAS GONE ON TO HAVE FURTHER PERIOPERATIVE COMPLICATIONS INCLUDING RUPTURED ESOPHAGUS, NEEDING BILATERAL CHEST TUBES. HE REMAINS IN ICU IN CRITICAL CONDITION. THE PATIENT UNFORTUNATELY IS DECEASED (B)(6), MULTI SYSTEM ORGAN FAILURE. AUTOPSY DECLINED BY FAMILY ".

  Patient problems: Respiratory Insufficiency; Stroke/CVA

  MAUDE report 24686968 ↗
• MalfunctionFeb 11, 2025Detachment of Device or Device Component; Mechanical Jam; Detachment of Device or Device Component; Mechanical Jam

  AS REPORTED: "THE GAMMA4 DEVICE AND THE NAIL ARE NO LONGER DISCONNECTED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354833 ↗