MAUDE Adverse Event Report: ARTHREX, INC. HEADED REAMER, 8.5 MM CANNULATED; ORTHOPEDIC MANUAL SURG INSTR

Model Number	HEADED REAMER, 8.5 MM CANNULATED
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2025
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, it was reported by a sales representative via email that an ar-1408.5, cannulated headed reamer, 8.5 mm, was blunt.This was detected during use in an acl reconstruction procedure on (b)(6) 2025 where the acl reamer took 20 seconds to drill through the tibia.The surgeon looked very concerned for the patient's health.The procedure was completed successfully by using the reamer.The evaluation on whether there was patient harm was not evident at that point in time.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6 complaint allegation is confirmed.Upon visual inspection, it was noted that the edges of the flute were blunt/rounded.Functional testing was not performed due to the damage to the device.The most likely cause of this failure is attributed to wear and tear damage incurred over repeatedly drilling and extended use in the field.Manufacturing date 2016.
Event or Problem Description
Additional information: while there was a concern of necrosis, follow-up indicated that necrosis did not occur.

• Brand Name: HEADED REAMER, 8.5 MM 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: 21594986
• Report Number: 1220246-2025-00921
• Device Sequence Number: 18362430
• Product Code: LXH
• UDI-Device Identifier: 00888867016712
• UDI-Public: 00888867016712
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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, 8.5 MM CANNULATED
• Device Catalogue Number: AR-1408.5
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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