MAUDE Adverse Event Report: ARTHREX, INC. GALILEO LAG SCREW, RIGHT, Ø10.5MMX95MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	GALILEO LAG SCREW, RIGHT, Ø10.5MMX95MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/21/2024
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
On 09/03/2024, it was reported by a sales representative via (b)(4) that a 5033-100 capturing rod assembly was cold-welded with the screw.This occurred during a revision troch nail procedure when the surgeon removed our troch nail and implanted a synthes nail when the galileo capturing rod cold welded to the screw upon removal.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged 1099-095 telescoping lag screw, 10.5mm x 95mm serial/batch number (b)(6) was received for evaluation.The device was received with the 5033-100 galileo® capturing rod batch 212533 stuck inside.Visual inspection revealed that the telescoping lag screw which was broken at the distal end separating the threaded shaft from the barrel.Multiple scratches were noted on the barrel, the locking ring, and the locking sleeve.The more in-depth visual evaluation revealed that the barrel teeth were bent.Evaluation of the threaded shaft revealed nicks at the threads.The device was received with a metal guide stuck inside the threaded rod, which was bent.No allegation against the metal guide stuck inside the piece of the threaded rod of the telescoping lag screw was received.The most likely cause(s) of the reported failure is user error, excessive force application, or misalignment during the removal process.
Event or Problem Description
On 9/10/2024 additional information was received by a sales representative via email who stated that the procedure performed was a subtrochanteric hip fracture.The lag screw broke in the patient's femoral head.The date of the initial procedure was (b)(6) 2024.A picture attached shows all the parts used in the initial procedure.An arthrex rep was present.A standard 10.3 drill in the torch nail set was used to prepare the bone socket for insertion.All fragments were retrieved from the patient.To complete the procedure, a standard removal instrumentation for the lateral body of the lag screw.The surgeon used a conical extractor from the aos 7.0 screw set and removed the purple broken screw threads halfway and then bent a 2.0 k wire into the cannula of the screw and removed from the femoral head.It was unknown if there were delays or if additional anesthesia was needed.
Additional Manufacturer Narrative
Additional information: b4, b5, g3, h6.

• Brand Name: GALILEO LAG SCREW, RIGHT, Ø10.5MMX95MM
• 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: 20522252
• Report Number: 1220246-2024-08232
• Device Sequence Number: 21124921
• Product Code: HSB
• UDI-Device Identifier: 00848665015843
• UDI-Public: 00848665015843
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K120148
• 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,Followup,Followup
• Report Date (Section B): 12/20/2024

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, Ø10.5MMX95MM
• Device Catalogue Number: 1099-095
• Device Lot Number: 212633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 11/08/2024; 09/10/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 12/05/2024; 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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