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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
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 06/05/2025, it was reported by a sales representative via (b)(4) that an 1280-000 retrograde targeting guide broke off inside the patient where the nail attached.The broken pieces were retrieved.This was discovered during the case with no patient harm.
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 likely cause of the reported failure is wear and tear damage incurred during repeated insertion/removal processes and/or user-applied excessive mechanical forces used during extended use in the field.

• 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: 22347098
• Report Number: 1220246-2025-02690
• Device Sequence Number: 14674772
• Product Code: HSB
• UDI-Device Identifier: 00848665017038
• UDI-Public: (01)00848665017038(11)211021(10)212055
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K132005
• 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): 09/10/2025

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: 212055
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown