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

Model Number	GALILEO® LAG SCREW INSERTER
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
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 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
Additional information: b5, d9, g3, h3, h6.Complaint allegation is not confirmed.One unpackaged, 5030-000, galileo lag screw inserter, serial/batch number 220669, was received for investigation.Visual evaluation found normal signs of wear: fading and discoloration.The manufacturing date is 2022.Functional testing with a known good part, found that the hex driver mated with the lag screw as intended.Proper alignment was observed.No problem found.
Event or Problem Description
Additional information was received on (b)(6) 2025: this was discovered during a hip fracture procedure on (b)(6) 2024.There were no adverse effects on the patient reported.

• 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: 21085194
• Report Number: 1220246-2025-09235
• Device Sequence Number: 6907563
• Product Code: HSB
• UDI-Device Identifier: 00848665036244
• UDI-Public: (01)00848665036244(11)220824(10)220669
• 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
• Report Date (Section B): 02/11/2025

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: 220669
• 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: 02/10/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2022
• 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