MAUDE Adverse Event Report: ARTHREX, INC. MINIMALLY INVASIVE BUNION CORR SYSTEM; MANUAL INSTR, GENERAL SURGICAL

Model Number	MINIMALLY INVASIVE BUNION CORR SYSTEM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/14/2024, it was reported by a sales representative via (b)(4) that an ar-8741c instrument case minimally invasive bunion correction systems driver broke.This occurred during a case causing extra or time to retrieve the broken piece, as well as creating larger incisions to do so (defeating the purpose of the procedure name).
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user-applied excessive force during the tightening process.

• Brand Name: MINIMALLY INVASIVE BUNION CORR SYSTEM
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 20530154
• Report Number: 1220246-2024-08260
• Device Sequence Number: 6681503
• Product Code: MDM
• UDI-Device Identifier: 00888867367548
• UDI-Public: 00888867367548
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 07/07/2025

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: MINIMALLY INVASIVE BUNION CORR SYSTEM
• Device Catalogue Number: AR-8741C
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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