MAUDE Adverse Event Report: ARTHREX, INC. GALILEO® LOCKING TOOL; INTRAMED FIXATN ROD AND ACCESS

Model Number	GALILEO® LOCKING TOOL
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/30/2021, it was reported by an arthrex employee via email that a 5 031-100 lag screw locking tool may have been in question for reliability and performance of the torque limiter when it was used to lock a 1099-095 telescoping lag screw.This was discovered post-operative of a trochanteric femoral nail procedure that was performed on (b)(6)2021.When the surgeon x-rayed the patient, it was notices that the telescoping lag screw did not stay locked up.Prior to this, the trochanteric femoral nail procedure had been successfully completed with no issues, no broken implants and or instruments.At this time there has been no revision surgery has been scheduled.
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 device was evaluated by (b)(6).No deviation or issues with the torque limit on the device.The torque measured exactly at 80 in lbs as designed.

• Brand Name: GALILEO® LOCKING TOOL
• 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: 19375823
• Report Number: 1220246-2024-03677
• Device Sequence Number: 7618750
• Product Code: HSB
• UDI-Device Identifier: 00848665031522
• UDI-Public: 00848665031522
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K202099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

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: GALILEO® LOCKING TOOL
• Device Catalogue Number: 5031-000
• Device Lot Number: 212675-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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