MAUDE Adverse Event Report: ARTHREX, INC. HEADED REAMER 9MM, CANNULATED; ORTHOPEDIC MANUAL SURG INSTR

Model Number	HEADED REAMER 9MM, CANNULATED
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 3rd june 2025, it was reported by an arthrex employee via email that an ar-1409, cannulated headed reamer, 9 mm, was blunt.This was detected during use in an acl procedure on (b)(6) 2025.The procedure was completed successfully as they opened a single use sharp reamer.
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 reason for the reported failure is the wear and tear damage incurred over repeated usage.

• Brand Name: HEADED REAMER 9MM, CANNULATED
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 22296517
• Report Number: 1220246-2025-02576
• Device Sequence Number: 8893169
• Product Code: LXH
• UDI-Device Identifier: 00888867016743
• UDI-Public: (01)00888867016743(11)201214(10)022044
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: HEADED REAMER 9MM, CANNULATED
• Device Catalogue Number: AR-1409
• Device Lot Number: 022044
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2020
• 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