MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX®; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	AR-4030C-09
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Arthrex implant fastthread biocomposite screw 9x30 mm with ref# ar-4030c-09, lot# 15295595 , exp 06/30/2028 broke.

• Brand Name: ARTHREX®
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd; naples FL 34108
• MDR Report Key: 23423851
• Report Number: 23423851
• Device Sequence Number: 8178979
• Product Code: MAI
• UDI-Device Identifier: 00888867277663
• UDI-Public: (01)00888867277663
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2025
• Report Date (Section F): 10/08/2025

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: AR-4030C-09
• Device Catalogue Number: AR-4030C-09
• Device Lot Number: 15295595
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Male
• Date Report Sent to FDA: 10/08/2025