GAMMA 3125-2170SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540375094), received between Oct 27, 2023 and Nov 21, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Damaged by Another 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2023Device Damaged by Another Device; Device Damaged by Another Device

  AS REPORTED: "INTRAOPERATIVE INTERFERENCE BETWEEN THE STEP DRILL AND THE NAIL WAS OBSERVED. THE NAIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT PROBLEMS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18182537 ↗
• InjuryOct 27, 2023Device Difficult to Setup or Prepare; Noise, Audible; Device Difficult to Setup or Prepare; Noise, Audible

  AS REPORTED: "THE SET SCREW GOT STUCK IN THE MIDDLE OF THE NAIL AND THE SCREWDRIVER FOR THE SET WAS NOT TURNING HALFWAY. WHEN TIGHTENED HARD, IT MADE A CREAKING SOUND AND THE SITUATION WAS COMPLETELY DIFFERENT FROM USUAL. WE TRIED A NEW SET SCREW, BUT THE RESULT WAS THE SAME. WE THOUGHT THAT THE NAIL WAS NOT GOOD, REMOVED IT, OPEN A NEW DIFFERENCE NAIL, AND PERFORM THE OPERATION. THE OPERATION TOOK TWICE AS LONG AS USUAL, PUTTING A BURDEN ON THE PATIENT, BUT IT WAS COMPLETED SUCCESSFULLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18020538 ↗