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

Model Number	GALILEO® LOCKING TOOL
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/07/2024 it was reported by a sales representative via (b)(4) that a 5030-000 galileo lag screw and a 5031-000 galileo locking tool disengaged when compression was applied resulting in the instruments not locking.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.One unpackaged 5031-000 galileo lag screw locking tool batch number: 220671-015 was received for investigation.Visual evaluation of the returned device noted normal wear and tear to the device.Functional testing was performed with a known good 5030-000 galileo lag screw inserter batch number: 212668 and it was noted that the returned 5031-000 galileo lag screw locking tool was able to mate and lock as intended.No problem found.

• Brand Name: GALILEO® LOCKING TOOL
• 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: 20461895
• Report Number: 1220246-2024-08158
• Device Sequence Number: 7880740
• Product Code: HSB
• UDI-Device Identifier: 00848665031522
• UDI-Public: (01)00848665031522(11)221014(10)220671
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/04/2025

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® LOCKING TOOL
• Device Catalogue Number: 5031-000
• Device Lot Number: 220671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2022
• 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