MAUDE Adverse Event Report: ARTHREX, INC. GALILEO® CAPTURING ROD; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	GALILEO® CAPTURING ROD
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/21/2025, a sales representative reported via (b)(4) that an 5033-100 capturing rod assemblys galileo lag screw was loaded onto the handle and capture rod.When the screw was advanced over the 3.2mmx 381mm guide wire it got stuck.After removing the guide wire and then readvancing the screw the handle was disengaged from the screw and the capture rod was inspected.The top portion of the rod was broken off on the mayo stand.An x-ray was obtained to confirm no portion of the rod was left inside of the patient.The procedure was completed without any additional time or issues.Additional information was provided on 07/24/2025 where the sales representative stated this event occurred during a intertrochanteric fracture.The device broke at the threads where the nut attaches when it was placed over the guidewire.The patients bone was soft, all fragments were retrieved.The cases was completed using a second capturing rod from the instrument set.There were no major delays, and no additional anesthesia was delivered.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure can be attributed to user error of the device due to user-applied mechanical forces, misaligned insertion, and/or prying/leveraging during use.

• Brand Name: GALILEO® CAPTURING ROD
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 22748413
• Report Number: 1220246-2025-03342
• Device Sequence Number: 9557995
• Product Code: HSB
• UDI-Device Identifier: 00848665039177
• UDI-Public: 00848665039177
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K202099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GALILEO® CAPTURING ROD
• Device Catalogue Number: 5033-100
• Device Lot Number: 203143
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown