MAUDE Adverse Event Report: ARTHREX, INC. CORING REAMER, 9MM WITH COLLARED PIN; ORTHOPEDIC MANUAL SURG INSTR

Model Number	CORING REAMER, 9MM WITH COLLARED PIN
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
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 (b)(6) 2025, an arthrex subsidiary employee reported via (b)(4) that an ar-1223s 9mm cannulated coring reamer trephine opened too wide and lost its intended function.This occurred during an acl reconstruction, and no patient was affected.The procedure was completed by opening a second trephine.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is confirmed by the attached picture, which shows the distal end of the coring reamer at the teeth end bent and damaged.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.Per dfu-0070-eo - e.Warnings - 9.Coring reamers only: excess drilling force in conjunction with any angulation changes of the drill during reaming may result in coring reamer deviation or failure of the device.The most likely cause of the reported failure can be attributed to user-applied excessive mechanical forces, misaligned insertion, and/or prying or leveraging the device during the drilling process.

• Brand Name: CORING REAMER, 9MM WITH COLLARED PIN
• 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: 23300174
• Report Number: 1220246-2025-04605
• Device Sequence Number: 14668443
• Product Code: LXH
• UDI-Device Identifier: 00888867005532
• UDI-Public: 00888867005532
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 02/05/2026

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: CORING REAMER, 9MM WITH COLLARED PIN
• Device Catalogue Number: AR-1223S
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown