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

Model Number	GALILEO® LOCKING TOOL
Medical Device Problem Codes	Positioning Failure (1158); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/10/2024, it was reported by a sales representative via (b)(4) that a 5030-000 galileo lag screw inserter and a 5031-000 locking tool assembly galileo lag screw were not engaging to each other properly to lock the lag screw.The case was completed using an end cap without harm to the patient, but it was stated that there could be a greater chance for lateralization of the screw potentially.There was a few-minute delay in the case.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Event or Problem Description
Additional information was received on 01/16/2025: this was discovered during a hip fracture procedure on (b)(6) 2024.There were no adverse effects on the patient reported.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged, 5031-000, locking tool assembly galileo lag screw, serial/batch number (b)(6), was received for investigation.Visual evaluation noted that one of the "castle pieces" on the distal end is bent.Additionally, normal signs of wear were observed: fading and discoloration.Functional testing was not performed due to the damage of the device.The most likely cause for the reported failure can be attributed to misuse due to excessive user-applied mechanical forces.

• 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: 21085199
• Report Number: 1220246-2025-09236
• Device Sequence Number: 6907567
• Product Code: HSB
• UDI-Device Identifier: 00848665031522
• UDI-Public: (01)00848665031522(11)221014(10)220671
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 02/21/2025

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: 12/10/2024
• Supplement Date Received by Manufacturer: Not provided; 02/10/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 02/05/2025; 02/21/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown