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	10/19/2025
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 23rd oct 2025, it was reported by an arthrex's employee via an email that for 1 unit of ar-8400td, torpedo, 4.0 mm x 13 cm, the shaver blade broke when retrieving it.All fragments were retrieved from the patient.This was detected during an acl reconstruction surgery on (b)(6) 2025.The procedure was completed successfully by using a new ar-8400td.There were no patient harm and no secondary procedure needed.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on photographic evidence of the ar-8400td torpedo (batch 15290728), which showed the device to be fractured and disassembled.Based on the information provided, which may include the returned device (if available), photographs, videos, the event description, and any additional field input, arthrex has determined the most likely cause of the reported failure.The most likely cause is attributed to misuse of the device, including exposure to excessive mechanical forces, misaligned insertion, and/or side-loading during use.

• 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: 23390776
• Report Number: 1220246-2025-04829
• Device Sequence Number: 9844557
• Product Code: GFA
• UDI-Device Identifier: 00888867043657
• UDI-Public: (01)00888867043657(11)240722(17)290630(10)15290728
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/03/2026

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: 15290728
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2024
• 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