MAUDE Adverse Event Report: ARTHREX, INC. 4MM CURVED TORPEDO; SAW BLADE

Model Number	4MM CURVED TORPEDO
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2025
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 07/29/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-8400ctd torpedo disassembled.This occurred during use when the consumable was passed to be placed in the handpiece, it was disassembled.An attempt was made to use it, but it was not stable and did not perform the oscillation function properly, so another consumable had to be used to solve the problem.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the customer-provided pictures.Visual evaluation of the customer-provided pictures noted a disassembled ar-8400ctd.Refer to attachments.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure can be attributed to user error of the device due to prying/leveraging the device during use.

• Brand Name: 4MM CURVED TORPEDO
• 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: 22803654
• Report Number: 1220246-2025-03488
• Device Sequence Number: 21098219
• Product Code: GFA
• UDI-Device Identifier: 00888867187801
• UDI-Public: (01)00888867187801(11)240708(17)290630(10)15284291
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 12/12/2025

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: 4MM CURVED TORPEDO
• Device Catalogue Number: AR-8400CTD
• Device Lot Number: 15284291
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown