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

Model Number ARTHREX GEMINI SR8

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/24/2023

Event Type  malfunction  

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 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.

• Brand Name: ARTHREX GEMINI SR8
• Type of Device: 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
• MDR Text Key: 328981572
• Report Number: 1220246-2023-08812
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867040434
• UDI-Public: 00888867040434
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARTHREX GEMINI SR8
• Device Catalogue Number: AR-6572
• Device Lot Number: 062303
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1