GAMMA 1320-3042SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540377890), received between Jun 18, 2018 and Nov 25, 2024 — classified as 4 injuries, 2 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.

• MalfunctionNov 25, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "WHEN DOING A SHORT NAIL WE USE THE 180MM NAIL MOST EVERY TIME. WE HAD A FIRST SCRUB THAT HAD NEVER USED THE SYSTEM AND THEREFORE WE HELP HAVE EVERYTHING READY PRIOR TO THE START OF THE CASE INCLUDING THE 180 TARGET SLEEVE ON THE INTRODUCER. DR USED A 170 NAIL AND NOT THE 180 LIKE WAS PLANNED. THE NAIL WAS PLACED BUT BECAUSE OF THE DIFFERENT LENGTHS WHEN DRILLING FOR THE DISTAL LOOKING SCREW WE HIT THE NAIL BECAUSE PRIOR TO THE CASE WE SET UP FOR OUR STANDARD 180 NAIL. BROKE THE DRILL BIT TRADED THE SLEEVE AND OPENED A NEW DRILL BIT." ALL DEBRIS WAS REMOVED AND DISPOSED OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20775407 ↗
• InjuryOct 3, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED BY THE CUSTOMER THAT THE "SINGLE USE 4.2 DRILL BIT SNAPPED INTO TWO WHILE DRILLING. ONE PIECE WAS STUCK INSIDE THE PATIENT'S FEMUR AND HAD TO BE REMOVED WITH KELLY FORCEPS." IT WAS LATER CONFIRMED BY THE SURGEON THAT THIS EVENT WAS CONFIRMED TO BE A USER ERROR WITH NO ISSUE WITH THE DRILL BIT ITSELF. THE NAIL WAS COMPLETELY BROKEN INTO 2 PIECES AT THIS POINT IN THE NAIL.

  Patient problems: Insufficient Information

  MAUDE report 20360342 ↗
• InjuryJul 20, 2020Fracture; Fracture

  AS REPORTED IN MEDWATCH (B)(4): "THE DOCTOR WAS DRILLING FOR DISTAL SCREW, NOTICED DRILL BIT BROKE, WAS ABLE TO RETRIEVE THE TIP BUT A SMALL PIECE WAS LEFT ON THE MUSCLE AS SEEN ON X-RAY AND PER DOCTOR."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10299945 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SURGEON DID A HEAD EXCHANGE DUE TO POSSIBLE INFECTION." GAMMA3 DRILL WAS USED IN THE PRIMARY SURGERY.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9485571 ↗
• MalfunctionJul 27, 2018Break; Detachment of Device or Device Component

  PRIMARY PROCEDURE, LEFT FEMUR. IT WAS REPORTED THAT THE SURGEON REMOVED THE TARGETER BEFORE LOCKING DISTALLY. WHEN THEN ATTEMPTING TO DRILL TO LOCK DISTALLY, THE TIP OF THE DRILL BIT BROKE OFF IN THE PATIENT. THE TIP REMAINED IN PATIENT. A SURGICAL DELAY OF 1 HOUR WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7727758 ↗
• InjuryJun 18, 2018Appropriate Device Problem Term/Code Not Available

  THIS PI IS FOR THE GAMMA3 DRILL AND BALL-TIPPED GUIDE WIRE (TRAUMA & EXTREMITY DEVICES) THAT WAS USED ON THE PATIENT DURING PRIMARY SURGERY WHILE IMPLANTING A RIGHT HIP: IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED. "PATIENT HAD AN INFECTION AND HAD SOME COMPONENTS EXCHANGED DURING THE I AND D".

  Patient problems: Unspecified Infection

  MAUDE report 7612025 ↗