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	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
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 10/22/2025, an arthrex subsidiary employee reported via (b)(4) that an ar-1223s 9mm cannulated coring reamer trephine lost its cutting ability and became stripped.It was necessary to open another trephine to complete the acl reconstruction.No patient was affected.
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 misuse/mishandling due to damage, causing the device to become worn and eventually unable to cut.

• 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: 23452756
• Report Number: 1220246-2025-04968
• Device Sequence Number: 18394284
• Product Code: LXH
• UDI-Device Identifier: 00888867005532
• UDI-Public: (01)00888867005532(11)250624(17)300531(10)15455258
• 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): 02/25/2026

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
• Device Lot Number: 15455258
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2025
• 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