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

Model Number	TRIPLEDAM CANNULA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the rotator cuff repair, a part of the cannula broke off and remained in the patient´s shoulder.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Based on photographic evidence of the damaged ar-6530td, batch 5174161215, the complaint allegation of damage to the device is confirmed.Visual inspection confirms damage to the cannula valve membrane, including a missing section of the valve.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 condition.The most likely cause is user-related, such as misaligned instrument insertion, prying, or leveraging forces applied to the valve during the procedure.

• 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: 24442125
• Report Number: 1220246-2026-00909
• Device Sequence Number: 10372715
• Product Code: NBH
• UDI-Device Identifier: 00888867118515
• UDI-Public: (01)00888867118515(11)250701(17)300630(10)5174161215
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

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
• Device Catalogue Number: AR-6530TD
• Device Lot Number: 5174161215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2025
• 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