GAMMA 8525-0300SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327474725), received between Oct 15, 2025 and Feb 12, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 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.

• InjuryFeb 12, 2026Fracture

  AS REPORTED: "AFTER THE INITIAL SURGERY, THE PATIENT WAS WALKING USING A WALKER. HOWEVER, PAIN DEVELOPED AROUND THE NEW YEAR OF 2026. UPON EXAMINATION ON (B)(6) IT WAS DETERMINED THAT THERE WAS A NONUNION AT THE FRACTURE SITE AND A FRACTURE AT THE LAG SCREW PORTION OF THE NAIL." THE PATIENT WAS REVISED ON (B)(6) 2026 TO BHA (BIPOLAR HEMIARTHROPLASTY).

  Patient problems: Ambulation or Postural Difficulties; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 24323847 ↗
• MalfunctionOct 29, 2025Use of Device Problem; Use of Device Problem

  AS REPORTED: "THE SURGEON PICKED UP THE NAIL FOR LEFT FOR RIGHT INTERTROCHANTERIC FEMUR FRACTURE BY MISTAKE AS BOTH RIGHT NAILS AND LEFT NAILS WERE STOCKED IN THE SAME BOX. THE SURGEON NOTICED IT WHEN THE X-RAY WAS TAKEN DURING INSERTION OF THE DISTAL LOCKING SCREW. AFTER REALIZING THE MISTAKE, THE NAIL WAS REMOVED AND REPLACED WITH ANOTHER ONE, AND THE SURGERY WAS COMPLETED. THE FRACTURE WAS FIRMLY FIXED, AND THERE ARE CURRENTLY NO REPORTS OF ANY HEALTH PROBLEMS TO THE PATIENT WHILE THE PROCEDURE TOOK APPROXIMATELY 15 MINUTES LONGER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417263 ↗
• InjuryOct 15, 2025Fracture; Fracture

  AS REPORTED: "THE ORIF WAS PERFORMED ON (B)(6) 2024 DUE TO LEFT FEMORAL TROCHANTERIC FRACTURE. ON (B)(6) 2025, THE SALES REP WAS CONSULTED BY THE DOCTOR ABOUT THE PATIENT'S BROKEN NAIL. BREAKAGE OF THE NAIL IN LUG POSITION WAS CONFIRMED. THE REVISION SURGERY TO REMOVE THE BROKEN NAIL WILL BE PERFORMED ON (B)(6) 2025.".

  Patient problems: Insufficient Information

  MAUDE report 23299567 ↗