MAUDE Adverse Event Report: ARTHREX, INC. TRIPLEDAM CANNULA; ARTHROSCOPIC ACCESSORIES

Model Number	TRIPLEDAM CANNULA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
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 5 june 2025, it was reported by an arthrex employee that an ar-6530td tripledam cannula, twist-in with valve 8.25 mm id x 7 cm, broke during use.This was discovered during a medial patello femoral ligament procedure.The broken piece was removed from the patient and the surgery was completed successfully.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 complaint allegation is confirmed by the attached picture, which shows a fragment of the cannula's cap broken.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 of the reported failure is user error in the device, which can be attributed to misalignment, prying/leveraging, and/or excessive force used during obturator insertion.

• Brand Name: TRIPLEDAM CANNULA
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• 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: 22337403
• Report Number: 1220246-2025-02670
• Device Sequence Number: 15734859
• Product Code: NBH
• UDI-Device Identifier: 00888867118515
• UDI-Public: (01)00888867118515(11)250101(17)291231(10)4331154863
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 09/29/2025

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: TRIPLEDAM CANNULA
• Device Catalogue Number: AR-6530TD
• Device Lot Number: 4331154863
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown