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

Model Number	GALILEO® LAG SCREW INSERTER
Medical Device Problem Code	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
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 12/06/2024, it was reported by a sales representative via (b)(6) 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
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged, 5031-000, galileo lag screw inserter, serial/batch number (b)(6), was received for evaluation.Visual inspection noted signs of wear along the t-handle and on the shaft.Functional testing of the mating part, 5030-000, with a good known device revealed that the devices do not lock as the connector had a small broken piece, which is thus related to the allegation.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• Brand Name: GALILEO® LAG SCREW INSERTER
• 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: 21067518
• Report Number: 1220246-2025-09190
• Device Sequence Number: 18235657
• Product Code: HSB
• UDI-Device Identifier: 00848665036244
• UDI-Public: (01)00848665036244(11)230116(10)220998A
• 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): 02/18/2025

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® LAG SCREW INSERTER
• Device Catalogue Number: 5030-000
• Device Lot Number: 220998A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown