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	03/02/2022
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 confirmed.Visual evaluation showed the locking key and pinch guard are dissembled from the device.The weld of pin that hold it together has broken off.Device functioning could not be performed due to the damaged of the device.The most likely cause for the reported failure is user error.Instruments must be handled with care.Overtightening or rough handling of the instrument may result in bending or breakage.
Event or Problem Description
On (b)(6) 2022 it was reported by a sales representative via sems that an 5030-000 galileo® lag screw inserter had an issue.While doing an in-service on (b)(6) 2022, a small piece popped off and the handle is now broken.This was discovered during use with no impact to the patient.

• 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: 19567901
• Report Number: 1220246-2024-06132
• Device Sequence Number: 12501325
• 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: 05/07/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2022
• 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