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 Codes	Positioning Failure (1158); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	06/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/23/2023, it was reported by a sales representative via email that a patient underwent a trochanteric nail procedure on 6/4/2023.After the surgery, an x-ray revealed that the 1099-095 lag screw shifted laterally.The patient is not in any discomfort or pain, and the implants remain in place.Cause for the shift in the lag screw is unknown.
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 cause for the reported failure can be attributed to improper bone prep, misaligned insertion.

• 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: 18190910
• Report Number: 1220246-2023-08865
• Device Sequence Number: 6646821
• Product Code: HSB
• UDI-Device Identifier: 00848665015843
• UDI-Public: 00848665015843
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K120148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Device Lot Number: 211477
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2022
• 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