MAUDE Adverse Event Report: ARTHREX, INC. TRIPLEDAM CANNULA, 7 MM ID X 7CM, VALVED; ARTHROSCOPIC ACCESSORIES

Model Number	TRIPLEDAM CANNULA, 7 MM ID X 7CM, VALVED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
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 11/26/2025, it was reported by a sales representative via (b)(4) that an ar-6570td tripledam cannula was defective.A piece of the cannula broke off and fell inside the patient and was retrieved successfully.This was discovered during a procedure with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, b5, g3, h6.
Event or Problem Description
Additional information provided (b)(6) 2026: it was further reported this was discovered during a shoulder scope procedure and a 10-minute delay occurred.The case was completed using the same cannula.Per rep, surgeon also had another of that same cannula in use as well as a passport cannula.It is unconfirmed if additional anesthesia was administered.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 the complaint allegation is confirmed.One unpackaged ar-6570td serial/batch number (b)(6) was received for investigation.Functional testing was not performed due to the damage of the device.Visual inspection noted that one side of the outer dam areas that help dissipate the fluid pressure to minimize squirting was broken off.Also, minor wear and tear, along with a scratch along the tip of the device, were noted.The most likely cause is attributed to misuse/use error due to the use of excessive force while handling the device.

• Brand Name: TRIPLEDAM CANNULA, 7 MM ID X 7CM, VALVED
• 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: 23826576
• Report Number: 1220246-2025-05647
• Device Sequence Number: 15710963
• Product Code: NBH
• UDI-Device Identifier: 00888867242555
• UDI-Public: (01)00888867242555(11)250601(17)300531(10)5153160646
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,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: TRIPLEDAM CANNULA, 7 MM ID X 7CM, VALVED
• Device Catalogue Number: AR-6570TD
• Device Lot Number: 5153160646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 01/14/2026; 02/25/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/22/2026; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2025
• 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