MAUDE Adverse Event Report: ARTHREX, INC. AUGMENTED VAULTLOCK TRIAL, MEDIUM 15R; ORTHOPAEDIC TEMPLATE

Model Number	AUGMENTED VAULTLOCK TRIAL, MEDIUM 15R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
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 (b)(6) 2023, it was reported by a sales representative via sems that an ar-9236-02ag-15r augmented glenoid trials central peg broke off.This occurred during a tsa- augmented vaultlock on (b)(6) 2023 after fully prepping the glenoid and inserting the pegged vaultlock trial, the central peg broke off the trial when the surgeon was pulling it out.The peg was then retrieved and the case was completed without incident.
Additional Manufacturer Narrative
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 user error of the device due to user-applied mechanical forces during extraction of the trial.

• Brand Name: AUGMENTED VAULTLOCK TRIAL, MEDIUM 15R
• Common Device Name: ORTHOPAEDIC TEMPLATE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 17003110
• Report Number: 1220246-2023-06784
• Device Sequence Number: 17929757
• Product Code: HWT
• UDI-Device Identifier: 00888867350816
• UDI-Public: 00888867350816
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/15/2024

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: AUGMENTED VAULTLOCK TRIAL, MEDIUM 15R
• Device Catalogue Number: AR-9236-02AG-15R
• Device Lot Number: NP215R000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2023
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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