MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX GEMINI SR8; ARTHROSCOPIC ACCESSORIES

Model Number	ARTHREX GEMINI SR8
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2025
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 8/1/2025, an fda medwatch notification was received via email.A facility representative reported that during arthroscopic surgery in (b)(6) 2025, the surgeon inserted an ar-6572 arthrex gemini sr8 self-retaining cannula system with a disposable cannulated obturator and a no-squirt cap.During insertion, the cannula broke, leaving a piece of the device inside the patient.The surgeon successfully located and removed the broken fragment without further complications.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 for the reported failure can be attributed to; misaligned insertion; prying/leveraging the device during insertion.As per bulletin instruction ue307.Align v-notch, red triangle, and red obturator arrow, then insert obturator.Ensure wings are captured by the distal tip of the obturator (note: if necessary, pinch the wings.Together so they are parallel to each other) insert the gemini cannula assembly into the joint (may be inserted over a 2.6 mm switching stick).Hold the clear inner cannula and remove the obturator.Squeeze the inner and outer cannula together to deploy wings.The inner cannula telescopes.Independently.

• Brand Name: ARTHREX GEMINI SR8
• 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: 22840191
• Report Number: 1220246-2025-03533
• Device Sequence Number: 17355786
• Product Code: NBH
• UDI-Device Identifier: 00888867040434
• UDI-Public: (01)00888867040434(11)250201(17)270131(10)022501
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 12/15/2025

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: ARTHREX GEMINI SR8
• Device Catalogue Number: AR-6572
• Device Lot Number: 022501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown