GAMMA 1320-0125Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04546540508003), received between Apr 22, 2019 and Sep 23, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Fracture” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Fracture

  As reported: "Fracture, Gamma3 clamping system."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870959 ↗
• MalfunctionNov 3, 2025Fracture; Fracture

  CUSTOMER REPORTED: GAMMA THREE COMPONENT BROKEN DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 23451428 ↗
• MalfunctionJun 5, 2025Break; Fracture; Break; Fracture

  A BROKEN INSTRUMENT WAS SENT BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150443 ↗
• MalfunctionMay 6, 2025Break; Fracture; Break; Fracture

  AS REPORTED: " 1 LOCKING SCREW INSERTER: BROKEN AT THE END WHICH ENTERS THE PATIENT." THE PROCEDURE WAS DELAYED BY APPROXIMATELY 1 HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21966708 ↗
• MalfunctionSep 20, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT: "A PIECE OF ANCILLARY EQUIPMENT IN OUR WAREHOUSE IS DEFECTIVE".

  Patient problems: Insufficient Information

  MAUDE report 20267992 ↗
• MalfunctionAug 5, 2024Break; Fracture; Break; Fracture

  TIP IS PARTIALLY BROKEN OFF DURING STERILIZATION TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19912050 ↗
• MalfunctionSep 19, 2023Break; Fracture; Naturally Worn; Break; Fracture; Naturally Worn

  AS REPORTED: "REF. 1320-0125 (CLOSED TUBE CLIP) BROKE." UPDATE: THE DEVICE WAS WORN AND DURING THE APPLICATION TO THE GAMMA HANDLE, IT BROKE ON THE TABLE IN THE OPERATING ROOM. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17777819 ↗
• MalfunctionSep 8, 2023Crack; Crack

  AS REPORTED: "I'VE RETURNED SOME FAULTY INSTRUMENTS." UPDATE: "FROM MEMORY AS FAR AS THE SCREWDRIVERS ARE CONCERNED, THEY WERE WORN OUT. FOR THE PART OF THE GAMMA NAIL, I THINK ONE OF THE ENDS WAS CHIPPED AND IT WAS AT THE REQUEST OF YOUR SALES REPRESENTATIVE THAT WE ASKED FOR A REPLACEMENT ON DEPOSIT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17715953 ↗
• MalfunctionMay 18, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "REF. 1320-0125 IS BROKEN.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16956631 ↗
• MalfunctionJan 4, 2023Break; Fracture; Material Fragmentation; Break; Fracture; Material Fragmentation

  AS REPORTED: "THERE WERE THREE GAMMA NAIL SURGERIES THAT DAY, AND THE PRODUCT IN QUESTION WAS USED IN THE FIRST OF THEM. WHEN THE PRODUCT WAS BEING PREPARED FOR USE IN THE THIRD SURGERY, A CHIP WAS FOUND ON THE TIP. IT WAS NOT USED IN THE SECOND SURGERY. THE CIRCUMSTANCES OF THE BREAK ARE UNKNOWN; IT IS POSSIBLE THAT IT OCCURRED DURING THE FIRST SURGERY AND A FRAGMENT IS LEFT IN THE BODY OF THE PATIENT, AND IT MAY HAVE OCCURRED DURING THE CLEANING PROCESS AFTER THE FIRST SURGERY."

  Patient problems: Foreign Body In Patient

  MAUDE report 16099086 ↗
• MalfunctionJul 25, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT "WE NOTICED DURING PACKAGING THAT THE TUBE WAS BROKEN, THIS DID NOT HAPPEN DURING AN OPERATION SO THERE WAS NO PATIENT IMPACT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15100154 ↗
• MalfunctionJun 23, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "TUBE CLAMP IS BROKEN OFF IN SEVERAL PLACES. THE EVENT WAS NOTICED AFTER MEDICAL PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14786314 ↗
• MalfunctionJun 13, 2022Break; Fracture; Break; Fracture

  THE INSTRUMENT BROKE DURING USE AFTER COMPLETION OF THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674819 ↗
• MalfunctionMay 21, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE INSTRUMENT IS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 14466052 ↗
• MalfunctionMay 20, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE INSTRUMENT IS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 14459141 ↗
• MalfunctionDec 12, 2020Fracture; Fracture

  TUBE CLIP BROKE ON THE UPPER RIGHT SIDE. SO A PIECE IS MISSING. MATERIAL WEAKENED, AND THEREFORE, NO LONGER USABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10996956 ↗
• MalfunctionAug 15, 2019Detachment of Device or Device Component

  THE LOCK CAME OFF. THE MEDICAL PROCEDURE WAS SUCCESSFULLY COMPLETED BY MANUALLY HOLDING THE TARGET DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8899238 ↗
• MalfunctionApr 22, 2019Break

  IT WAS REPORTED THAT, BEFORE SURGERY, THE STAFF OF THE OPERATION ROOM NOTICED THAT THE TIP OF THE CLIP WAS BROKEN. THE SUBSEQUENT PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO SURGICAL DELAY OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8537088 ↗