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); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/06/2024, it was reported by a sales representative via (b)(4) that an 5031-000 locking tool and 5030-000 lag inserter were not able to work together in unison.This occurred during use in a case with no patient effect.
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 confirmed.One unpackaged 5031-000 serial/batch number (b)(6) was received for evaluation.Functional testing with a good known device it was determined that the device doesn't lock to the 5030-000.A visual inspection revealed a small broken piece of the connector.Signs of wear and tear was noted on the shaft.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• 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: 21066923
• Report Number: 1220246-2025-09186
• Device Sequence Number: 3409913
• Product Code: HSB
• UDI-Device Identifier: 00848665031522
• UDI-Public: (01)00848665031522(11)221014(10)220671
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

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: 12/06/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/14/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown