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

Model Number	TORPEDO, 4.0MM X 13CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
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 10/08/2025, a facility representative reported via (b)(4) that an ar-8400td 4 mm x 13cm torpedo broke within a patient during a shoulder arthroscopy.The broken piece was retrieved from the patient, and the procedure was completed with no patient affected.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-8400td, torpedo, batch 15449195, was received for investigation.Visual inspection noted significant surface damage on the outer hood and a fracture at the tip of the inner tube.Functional testing was not performed due to the damage to the device.The most likely cause of the reported failure is attributed to user error, specifically, side-loading the device during use.Complaint confirmed.

• Brand Name: TORPEDO, 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: 23302448
• Report Number: 1220246-2025-04617
• Device Sequence Number: 17359364
• Product Code: GFA
• UDI-Device Identifier: 00888867043657
• UDI-Public: (01)00888867043657(11)250610(17)300531(10)15449195
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: TORPEDO, 4.0MM X 13CM
• Device Catalogue Number: AR-8400TD
• Device Lot Number: 15449195
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown