MAUDE Adverse Event Report: ARTHREX, INC. GALILEO® LAG SCREW INSERTER; MANUAL INSTR, GENERAL SURGICAL

Model Number	GALILEO® LAG SCREW INSERTER
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 5/12/2022, it was reported by a sales representative via email that an 5030-000 lag screw inserter pin popped out during the procedure, not allowing the surgeon to properly engage the lag screw locking tool.Upon removal o the 1192-120 lag screw, it was determined that it was missing the locking ring.Surgeon made sure it had not broken inside the patient and confirmed it did not; therefore determined it was missing upon opening package.A second lag screw was used and case was completed without further issues.This was discovered during an intertrochanteric fracture procedure on (b)(6) 2022.
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.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to user-applied mechanical forces during use.

• Brand Name: GALILEO® LAG SCREW INSERTER
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 19566162
• Report Number: 1220246-2024-06069
• Device Sequence Number: 6281419
• Product Code: HSB
• UDI-Device Identifier: 00848665036244
• UDI-Public: 00848665036244
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Administrator/Supervisor
• 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: 06/16/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown