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	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 (b)(6) 2024 it was reported by a sales representative via sems-06680482 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
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged 5030-000 galileo lag screw inserter batch number: 220669 was received for investigation.Visual evaluation of the returned device noted slight wear and tear with faded laser markings.Functional testing was performed with a known good 5031-000 galileo lag screw locking tool batch number: 212675-090 and it was noted that the 5030-000 galileo lag screw inserter would not mate and lock as intended.The sleeve of the 5030-000 galileo lag screw inserter was noted to be damaged during functional testing.The most likely cause for the reported failure can be attributed to overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging from repetitive use.Date of manufacture: 24-aug-2022.

• 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: 20508704
• Report Number: 1220246-2024-08212
• Device Sequence Number: 21124795
• Product Code: HSB
• UDI-Device Identifier: 00848665036244
• UDI-Public: (01)00848665036244(11)220824(10)220669
• 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): 01/30/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 01/30/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown