MAUDE Adverse Event Report: ARTHREX, INC. GALILEO® LAG SCREW INSERTER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	GALILEO® LAG SCREW INSERTER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
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.Complaint is confirmed.Visual evaluation confirms the pin was missing near the handle.Device functioning could not be performed due to the damaged of the device.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.
Event or Problem Description
On 01/25/2022, it was reported by a sales representative via sems that several instruments were broken/ not working correctly the 0312-200 lag screw triple sheath obturator( line#1) black release button would not disengage, the 5030-000 lag screw inserter (line#2) gold release mechanism broke the pin is missing that keeps it together, and the 0616-000 lag screw (line#3) obturator black knob at the end popped off while getting the triple sheath down to bone.This was discovered during use in a troch nail on (b)(6) 2022.No patient affect reported.There was no additional information provided.

• Brand Name: GALILEO® LAG SCREW INSERTER
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 19568883
• Report Number: 1220246-2024-06181
• Device Sequence Number: 6954322
• Product Code: HSB
• UDI-Device Identifier: 00848665036244
• UDI-Public: 00848665036244
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2024

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® LAG SCREW INSERTER
• Device Catalogue Number: 5030-000
• Device Lot Number: 212668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2021
• 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