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	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 04/11/2024, it was reported by a sales representative via (b)(4) that (2) 5033-100 capturing rods tips broke off in the 5046-100 capturing rod nut.This occurred during an aos troch nail while inserting the lag screw for the torch nail, the tip broke off with the nut that screws onto the back of the tool.The surgeon was able to remove everything safely with no harm to the patient.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged 5046-100 serial/batch number (b)(6) was received for investigation.Upon visual inspection, it was determined that the hex thread on the returned capturing rod nut had become detached.No functional testing was performed due to the damaged to the device.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• 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: 19250272
• Report Number: 1220246-2024-02837
• Device Sequence Number: 7309939
• Product Code: HSB
• UDI-Device Identifier: 00848665039160
• UDI-Public: 00848665039160
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 08/29/2024

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® CAPTURING ROD NUT
• Device Catalogue Number: 5046-100
• Device Lot Number: 212975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• 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