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	11/11/2025
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 11/11/2025, it was reported by a sales representative via (b)(4) that an ar-8400td torpedo encountered an old stitch from a prior repair and a piece of metal from the inner shaver blade broke off.The piece of metal got lodged in the shaver and was recovered.This was discovered during a meniscal debridement case.Another device was used to complete the case with no patient harm.Additional information was reported by the rep on 11/17/25.There was no outflow tubing used in the case.Irrigation flow was normal without interruption during the case.As a result of the shaver blade tip breaking and lodging into the shaver, the handpiece was damaged.A new shaver hand piece and shaver blade were used to complete the case.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-8400td torpedo shaver blade was received for evaluation.Visual inspection noted surface damage to both the inner and outer hoods, and a circumferential fracture of the outer hood.Functional testing was not performed due to the extent of the damage observed.Based on the available information, the most likely cause of the reported failure is attributed to use-related mechanical overload, such as contact with non-tissue materials during operation, resulting in tip fracture and subsequent device damage.The complaint allegation is confirmed based on the condition of the returned device.Refer to the investigation photos for additional detail.

• 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: 23692871
• Report Number: 1220246-2025-05301
• Device Sequence Number: 9211099
• Product Code: GFA
• UDI-Device Identifier: 00888867043657
• UDI-Public: 00888867043657
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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