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	11/20/2025
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 (b)(6) 2025, a sales representative reported via phone that an ar-8400td torpedo device broke during a shoulder arthroscopy procedure.The inner blade tip fractured within the device during use.An x-ray was performed to confirm that no fragments remained in the patient.All fragments were accounted for.The event resulted in an approximately 35-minute delay, requiring additional anesthesia.The procedure was completed using another ar-8400td torpedo, and no harm or adverse effects to the patient were reported.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 a most likely cause.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• 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: 23760135
• Report Number: 1220246-2025-05538
• Device Sequence Number: 13294698
• Product Code: GFA
• UDI-Device Identifier: 00888867043657
• UDI-Public: (01)00888867043657(11)250722(17)300630(10)15470238
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/13/2026

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: 15470238
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown