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	10/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 10/27/2023, it was reported by a sales representative via sems-06068646 that an ar-6572 cannula wings on the blue plastic part seemed to be broken.This occurred during a case on (b)(6) 2023 prior to inserting the anchor.The case was completed using a different cannula.
Additional Manufacturer Narrative
Additional information: b5, 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(s) of the reported failure can be user error mishandling the device.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was provided.
Event or Problem Description
Additional information was provided on 10/30/2023, where the sales representative reported that this event occurred during a labrum repair.The device did not break inside the patient.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18172495
• Report Number: 1220246-2023-08812
• Device Sequence Number: 7611625
• Product Code: NBH
• UDI-Device Identifier: 00888867040434
• UDI-Public: 00888867040434
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 02/07/2025

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 Expiration Date: 05/31/2025
• Device Model Number: ARTHREX GEMINI SR8
• Device Catalogue Number: AR-6572
• Device Lot Number: 062303
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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