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

Model Number	GALILEO® CAPTURING ROD NUT
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
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 02/25/2025, it was reported by a sales representative via (b)(4) that a 5046-100 lag screw capturing rod nut and a 5033-100 capturing rod assembly had an issue with not locking the lag screw into the nail as designed and had to use the locking end cap instead.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged 5046-100 lag screw capturing rod nut batch number: 220989 was received for investigation.Visual evaluation of the returned device noted superficial wear and tear to the device with scratches and faded laser markings observed.The most likely cause for this can be attributed to wear and tear incurred through extended use in the field/repeated reprocessing.Manufactured date: 12-oct-2022.It was further noted that the 5046-100 lag screw capturing rod nut had been improperly threaded onto the 5033-100 capturing rod and the devices could not be separated.Functional testing was not able to be performed due to the damage to the device.The most likely cause for the reported failure can be attributed to misuse due to use error when threading the mating devices.

• Brand Name: GALILEO® CAPTURING ROD NUT
• 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: 21585854
• Report Number: 1220246-2025-00901
• Device Sequence Number: 18508582
• Product Code: HSB
• UDI-Device Identifier: 00848665039160
• UDI-Public: (01)00848665039160(11)221012(10)220989
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 06/27/2025

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 NUT
• Device Catalogue Number: 5046-100
• Device Lot Number: 220989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2022
• 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