MAUDE Adverse Event Report: ARTHREX, INC. GALILEO LAG SCREW, RIGHT, Ø10.5MMX105MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	GALILEO LAG SCREW, RIGHT, Ø10.5MMX105MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	11/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during an intertrochanteric fracture surgery the lag screw and anti-rotation screw backed out of the nail and the nail lagscrew hole looked damaged.It was further reported that the patient went in for a total hip replacement on the (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Event or Problem Description
Update 25-feb-2025.Further information was provided that the initial surgery was performed successfully.No further information was provided.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Visual inspection, it was noted that all threads of the galileo lag screw, right, ø10.5mmx105mm had been damage and bent.Functional testing was not performed due to the damage to the device.Per surgical technique nail system: push the compression sleeve towards the targeting arm and rotate clockwise until it makes contact.If intraoperative compression is desired, continue rotating the compression sleeve clockwise until compression is achieved.The mechanism will stop advancing and spin in place showing a red line when the lag screw is too lateral and can no longer be locked.If this occurs, the lag screw should be inserted further into the head and the compression knob used again.The most likely cause for the reported failure can be attributed to user error of the device due to misaligned insertion.

• Brand Name: GALILEO LAG SCREW, RIGHT, Ø10.5MMX105MM
• 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: 21393428
• Report Number: 1220246-2025-00461
• Device Sequence Number: 15550747
• Product Code: HSB
• UDI-Device Identifier: 00848665015867
• UDI-Public: 00848665015867
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: GALILEO LAG SCREW, RIGHT, Ø10.5MMX105MM
• Device Catalogue Number: 1099-105
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: Not provided; 06/24/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/12/2025; 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown