GAMMA 1320-0191Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540713421), received between Mar 4, 2020 and Aug 21, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT: "THE AUGER WAS DAMAGED WHEN IT RUBBED AGAINST A COMPONENT DURING THE SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861641 ↗
• MalfunctionMay 12, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  AS REPORTED: "THE SURGEON REPORTS A PROBLEM WITH A GAMMA NAIL. THE LAG SCREW STEP DRILL IS TWISTED. "

  Patient problems: Insufficient Information

  MAUDE report 22004298 ↗
• MalfunctionMay 18, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "BROKEN PIECE AT SAN GERARDO HOSPITAL.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16956876 ↗
• MalfunctionJun 29, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE DEVICE WAS NOT PASSING THROUGH.

  Patient problems: Insufficient Information

  MAUDE report 14852484 ↗
• InjuryJun 27, 2022Break; Fracture; Break; Fracture

  THE FRONT PART OF A STEP DRILL (1320-0191) BROKE OFF DURING SURGERY AT (B)(6). THE BROKEN-OFF PART IS STILL IN THE PATIENT'S BONE. THE PROCEDURE WAS DELAYED BY 60 MIN.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14830633 ↗
• InjuryMar 4, 2020Fracture; Fracture

  SALES REP REPORTED THAT: "BREAKAGE OF THE GAMMA3 AUGER IN PER-OP. THE TIP OF THE AUGER REMAINED IN THE PATIENT IN THE FEMORAL HEAD. WE HAD TO LEAVE THE TIP OF THE AUGER IN THE FEMORAL HEAD, AS IT CANNOT BE REMOVED DESPITE EXTRACTION ATTEMPTS. A SHORTER CEPHALIC SCREW WAS INSTALLED, STOPPING JUST BEFORE THE BROKEN AUGER TIP." ADDITIONAL INFORMATION: DURING THE DRILLING AND THEN THE SCOPIC CONTROL, THE SURGEON NOTICED THAT 10MM WAS MISSING FROM THE LEVEL OF THE AUGER THAT BROKE INSIDE THE NECK WITHOUT ANY STRESS ON THE DRILL BIT. RE - INTERVENTION REQUIRED TO REMOVE THE PART OF THE DRILL BIT THAT WAS LEFT IN PLACE AND RETAKE IT, COMPLETE OSTEOSYNTHESIS.

  Patient problems: Device Embedded In Tissue or Plaque; Injury

  MAUDE report 9787950 ↗