MAUDE Adverse Event Report: ARTHREX, INC. GALILEO® CAPTURING ROD; INTRAMED FIXATN ROD AND ACCESS

Model Number	GALILEO® CAPTURING ROD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via sems-06664365 that a 5033-100 capturing rod assembly has a broken fragment from cross-threading.It is believed that this happened in a previous case.There was no additional information was provided, and additional information has been requested.
Event or Problem Description
On 09/19/2024 additional information was received by a sales representative via email who stated that the procedure performed was a trochanteric nail.The device broke while cross threading the rod onto the capturing screw.No photos or videos were taken.No fragments were left in the patient.No delays and no need for additional anesthesia.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was noted that the capturing rod assembly had broken threads on one side of the distal ends of the threads.Laser marking had corrosion and faded.Functional testing was not performed due to the damage to the device.The most likely cause of the reported failure is a user error of the device due to misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: GALILEO® CAPTURING ROD
• 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: 20397189
• Report Number: 1220246-2024-08029
• Device Sequence Number: 14297555
• Product Code: HSB
• UDI-Device Identifier: 00848665039177
• UDI-Public: 00848665039177
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup,Followup
• Report Date (Section B): 01/21/2025

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® CAPTURING ROD
• Device Catalogue Number: 5033-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 09/19/2024; 12/26/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 12/20/2024; 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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