GAMMA 8125-2170SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327479348), received between Aug 28, 2024 and Mar 23, 2026 — classified as 1 death, 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• DeathMar 23, 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 11X180X125 NAIL WAS USED TO COMPLETE THE SURGERY".

  Patient problems: Respiratory Insufficiency; Stroke/CVA

  MAUDE report 24670353 ↗
• MalfunctionJan 22, 2026Positioning Failure

  AS REPORTED: "MIS-DRILLING OCCURRED WHEN DRILLING INTO THE DISTAL SCREW HOLE. THE ACCURACY OF THE TARGET DEVICE WAS CHECKED AFTER SURGERY, AND NO PROBLEMS WERE FOUND."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24152038 ↗
• InjuryOct 20, 2025Malposition of Device; Malposition of Device

  AS REPORTED: "THE INITIAL SURGERY TOOK PLACE ON (B)(6) 2025, XRAY IMAGE WAS THEN TAKEN ON (B)(6) 2025, ISSUE WAS FOUND THAT THE SHS MIGRATED MEDIALLY. EACH OPERATION WAS PERFORMED BY A DIFFERENT DOCTOR/CLINICAL TEAM; REVISION SURGERY PERFORMED ON (B)(6) 2025. RE-REVISION SURGERY PLANNED FOR (B)(6) 2025." THIS COMPLAINT CAPTURES THE 2ND PLANNED REVISION.

  Patient problems: Perforation

  MAUDE report 23342887 ↗
• InjuryOct 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "THE LAG SCREW CUT OUT. THE PATIENT HAD BEEN FOLLOWING INSTRUCTIONS. HOWEVER, THIS TIME IT WAS TRAUMATIC AVASCULAR NECROSIS CAUSED BY A FALL. THE EVENT WAS DISCOVERED ON (B)(6) 2025, AND THE NAIL WAS REMOVED AND AN ARTIFICIAL HEAD WAS IMPLEMENTED ON (B)(6) 2025."

  Patient problems: Fall; Necrosis; Perforation

  MAUDE report 23219834 ↗
• InjurySep 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "AFTER THE OPERATION, IT WAS CUT OUT."

  Patient problems: Perforation

  MAUDE report 23174948 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FROM A TROCHANTERIC NAIL GAMMA4 NAIL TO A TOTAL HIP DUE TO THE ROTATION OF LAG SCREW NOT BEING MAINTAINED.

  Patient problems: Insufficient Information

  MAUDE report 20091631 ↗