MAUDE Adverse Event Report: ARTHREX, INC. RETROGRADE TARGETING GUIDE; INTRAMED FIXATN ROD AND ACCESS

Model Number	RETROGRADE TARGETING GUIDE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/08/2025
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 07/08/2025, a sales representative reported via (b)(4) that an 1280-000 retrograde targeting guide snapped off.This occurred during a retrograde nail case (b)(6) 2025.The small tines that help connect the nail to the targeting guide snapped off.Multiple pictures showing the item number of the targeting guide and the pieces were able to be found.The surgery was able to be completed by using another targeting guide.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is confirmed.Upon visual inspection, it was noted that the two tips of the targeting guide were broken off.Functional testing was not performed due to the damage to the device.The most probable cause of the reported failure is user-applied excessive mechanical forces upon insertion/removal processes and/or misaligned insertion; prying/leveraging the device during use.

• Brand Name: RETROGRADE TARGETING GUIDE
• 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: 22665314
• Report Number: 1220246-2025-03145
• Device Sequence Number: 15360114
• Product Code: HSB
• UDI-Device Identifier: 00848665017038
• UDI-Public: (01)00848665017038(11)240320(10)240100
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K132005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: RETROGRADE TARGETING GUIDE
• Device Catalogue Number: 1280-000
• Device Lot Number: 240100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown