MAUDE Adverse Event Report: ARTHREX, INC. DISSECTOR, CURVED 4.0MM X 13CM; SAW BLADE

Model Number	DISSECTOR, CURVED 4.0MM X 13CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
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 12/18/2024 it was reported, by a sales representative via sems-06738194, that an ar-8400cds dissector was producing metal shavings.This occurred during a knee procedure when the shavings started falling into the knee.All the shavings were removed from the patients knee.
Additional Manufacturer Narrative
Correction: h6 health effect - impact code additional information: b5, g3, h3, h6 based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded the most likely cause.The most likely cause of the reported failure is misuse of the product, caused by the surgeon using excessive side-loading force and/or running the device without sufficient irrigation flow (dry).This misuse can cause the device to fail to operate as intended.Directions for use (dfu) disposable arthroscopic shaver blades, burrs, powerpick, powerasp, nanoresection and shaverdrill devices e.Warnings 5.Failure to use this device in accordance with the directions for use below may result in device failure, render the device unsuitable for its intended use, or compromise the procedure.F.Precautions 7.Excessive "side-loading" on the device during use does not improve cutting performance and, in extreme cases will cause irreversible damage to the device.9.Irreversible damage to all devices will result if they are run without the flow of irrigation (dry).The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was provided.
Event or Problem Description
Additional information was provided on 12/23/2024, where it was stated that this event occurred during a knee arthroscopy on (b)(6) 2024 where a replacement ar-8400cds was used to complete the case.There was minimal delay to open a new ar-8400cds and replace the one they were using and no additional anesthesia was administered.

• Brand Name: DISSECTOR, CURVED 4.0MM X 13CM
• Common Device Name: SAW BLADE
• 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: 21148779
• Report Number: 1220246-2025-09430
• Device Sequence Number: 13173047
• Product Code: GFA
• UDI-Device Identifier: 00888867043497
• UDI-Public: (01)00888867043497(11)240820(17)290731(10)15304621
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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: DISSECTOR, CURVED 4.0MM X 13CM
• Device Catalogue Number: AR-8400CDS
• Device Lot Number: 15304621
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown