MAUDE Adverse Event Report: ARTHREX, INC. 45MM PERIPHERAL REAMER; ORTHOPEDIC MANUAL SURG INSTR

Model Number	45MM PERIPHERAL REAMER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/29/2024
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) 2024, a sales representative reported via (b)(4) that an ar-9619-45 45mm reamer broke during a case.All broken pieces were retrieved, and the case was continued.Later, during the case, the ar-9530l-03 revers trial was used, and the rep noticed it had a lot of wear and tear and would need to be replaced for the next time.It was used a lot, and pieces were falling off.The rep confirmed nothing fell into the patient trial, and the case was completed successfully without a significant delay.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Visual evaluation of the customer-provided pictures noted an ar-9619-45 45mm reamer broke.Refer to attachments.The complaint allegation is confirmed based on the customer-provided pictures.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or prying/leveraging the device during use.

• Brand Name: 45MM PERIPHERAL REAMER
• 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: 20653742
• Report Number: 1220246-2024-08506
• Device Sequence Number: 20503631
• Product Code: LXH
• UDI-Device Identifier: 00888867308930
• UDI-Public: (01)00888867308930(11)191101(10)021939
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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: 45MM PERIPHERAL REAMER
• Device Catalogue Number: AR-9619-45
• Device Lot Number: 021939
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2019
• 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