MAUDE Adverse Event Report: ARTHREX, INC. DISSECTOR, CURVED, HL 4.2MM X 19CM; SAW BLADE

Model Number	DISSECTOR, CURVED, HL 4.2MM X 19CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/08/2025, it was reported by an arthrex employee via (b)(4) that an ar-6420cds dissector shaver blade broke.This was discovered during the case.There were no fragments and another device was used to complete the case with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint device was not received for evaluation.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 the most likely cause.The failure is most likely attributed to user error, specifically due to excessive side-loading force applied to the tip of the device.This force can cause the inner tube to break and result in the bending or warping observed on the outer tube.The complaint was confirmed based on the customer's attached picture, which shows the device disassembled, with the inner tube missing the tip and the outer tube bent/warped.

• Brand Name: DISSECTOR, CURVED, HL 4.2MM X 19CM
• 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: 21901835
• Report Number: 1220246-2025-01706
• Device Sequence Number: 8623386
• Product Code: GFA
• UDI-Device Identifier: 00888867039193
• UDI-Public: (01)00888867039193(11)240619(17)290531(10)15276050
• 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): 08/18/2025

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, HL 4.2MM X 19CM
• Device Catalogue Number: AR-6420CDS
• Device Lot Number: 15276050
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown