MAUDE Adverse Event Report: ARTHREX, INC. CRYSTAL CANNULA, PARTIALLY THREADED; ARTHROSCOPIC ACCESSORIES

Model Number	CRYSTAL CANNULA, PARTIALLY THREADED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
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 8/4/2025, an fda medwatch notification was received via email.A facility representative reported that an ar-6564 partially threaded cannula fractured at the tip during use in a patient¿s shoulder, resulting in a small fragment breaking off.The surgeon successfully retrieved and suctioned out the fragment without further complications.This was discovered during a procedure on (b)(6) 2025.Additional information was provided on 08/08/2025: this was discovered during a shoulder arthroscopy procedure on (b)(6) 2025.The case was completed using a replacement ar-6564 partially threaded cannula.There was no case delay or added anesthesia administered to the patient.There were no photos taken of this event.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-6564 partially threaded cannula, batch 5066157846, was received for investigation.Visual inspection revealed that the device's tip was fractured.Functional testing was not performed due to the damage.The most likely cause of the reported failure is user error, such as misaligned insertion and prying or leveraging the device during insertion.The complaint allegation is confirmed.Refer to the investigation photos.

• Brand Name: CRYSTAL CANNULA, PARTIALLY THREADED
• 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: 22872436
• Report Number: 1220246-2025-03583
• Device Sequence Number: 10386563
• Product Code: NBH
• UDI-Device Identifier: 00888867040342
• UDI-Public: (01)00888867040342(11)250401(17)300331(10)5066157846
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: CRYSTAL CANNULA, PARTIALLY THREADED
• Device Catalogue Number: AR-6564
• Device Lot Number: 5066157846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 08/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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