MAUDE Adverse Event Report: ARTHREX, INC. VIP¿ GLENOID REAMER, AUGMENTED MGS SMALL; MODULAR GLENOID SYSTEM

Model Number	VIP¿ GLENOID REAMER, AUGMENTED MGS SMALL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
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 5/16/2024, a sales representative reported via (b)(4) that an ar-5410-amgs-s vip glenoid reamer broke while reaming.All fragments were retrieved from the patient without adverse effects on the patient and with no case delay.The case was completed successfully by replacing it with another.This was discovered during a procedure, with no reported patient harm.Additional information was received on 5/20/2024: this was discovered during a reverse tsa with augmented baseplate on (b)(6) 2024.
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 descriptions, and any additional information from the field, arthrex was able to conclude the most likely cause.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• Brand Name: VIP¿ GLENOID REAMER, AUGMENTED MGS SMALL
• Common Device Name: MODULAR GLENOID SYSTEM
• 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: 19515059
• Report Number: 1220246-2024-05585
• Device Sequence Number: 3340978
• Product Code: KWS
• UDI-Device Identifier: 00888867409743
• UDI-Public: 00888867409743
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K222007
• 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): 06/25/2025

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: VIP¿ GLENOID REAMER, AUGMENTED MGS SMALL
• Device Catalogue Number: AR-5410-AMGS-S
• Device Lot Number: 15198109
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2024
• 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