MAUDE Adverse Event Report: ARTHREX, INC. GALILEO LAG SCREW, RIGHT, Ø10.5MMX95MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	GALILEO LAG SCREW, RIGHT, Ø10.5MMX95MM
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/27/2023, it was reported by a sales representative via email that an 1099-095 telescoping lag screw ring was prominent.This was discovered during a procedure on (b)(6) 2023.Additional information requested.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The complaint allegation was not confirmed.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely reason for the reported failure is user error due to mishandling the device.

• Brand Name: GALILEO LAG SCREW, RIGHT, Ø10.5MMX95MM
• 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: emily shafer ; 8009337001
• MDR Report Key: 18385469
• Report Number: 1220246-2023-09602
• Device Sequence Number: 11431569
• Product Code: HSB
• UDI-Device Identifier: 00848665015843
• UDI-Public: 00848665015843
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K120148
• 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): 01/07/2025

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, RIGHT, Ø10.5MMX95MM
• Device Catalogue Number: 1099-095
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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