MAUDE Adverse Event Report: ARTHREX, INC. GALILEO® CAPTURING ROD; INTRAMED FIXATN ROD AND ACCESS

Model Number	GALILEO® CAPTURING ROD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 05/08/2025, a sales representative reported via (b)(4) that an 5033-100 capturing rod assembly and an 5046-100 lag screw capturing rod nut broke.This occurred during a case.This occurred during a case on (b)(6) 2025.There was no additional information provided, and additional information has been requested.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the photograph submitted from the field.Consequently, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure is wear and tear incurred over repeated usage.The manufacturing date is september 2021.

• Brand Name: GALILEO® CAPTURING ROD
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• 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: 22106547
• Report Number: 1220246-2025-02277
• Device Sequence Number: 20613514
• Product Code: HSB
• UDI-Device Identifier: 00848665039177
• UDI-Public: (01)00848665039177(11)210929(10)212534
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/08/2025

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: 212534
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown