MAUDE Adverse Event Report: ARTHREX, INC. LOCKING TOOL, GALILEO® LAG SCREW; ORTHOPEDIC MANUAL SURG INSTR

Model Number	LOCKING TOOL, GALILEO® LAG SCREW
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 5/10/2022, it was reported by a sales representative via sems that while using an 0456-100 lag screw, a 0462-000 capturing rod, and a 0463-000 lag screw inserter, firm resistance is immediately felt when attempting to lock the lag screw well before resistance should be met.This occurred during a hip fracture with im nail procedure on (b)(6) 2022.Additional information requested.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to wear and tear.

• Brand Name: LOCKING TOOL, GALILEO® LAG SCREW
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 19483886
• Report Number: 1220246-2024-05197
• Device Sequence Number: 7905453
• Product Code: HSB
• UDI-Device Identifier: 00848665021448
• UDI-Public: 00848665021448
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 06/07/2024

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: LOCKING TOOL, GALILEO® LAG SCREW
• Device Catalogue Number: 0456-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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