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

Model Number	AUGMENTED VAULTLOCK TRIAL, MEDIUM 15R
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
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 9/20/2023, it was reported by a sales representative via sems-06036695 that an ar-9236-02ag-15r univers vaultlock augmented glenoid trial, medium 15 ° right, had an issue during a tsa-eclipse procedure pm (b)(6) 2023.When removing the pegged augment trial, the central peg cracked right before it was completely out of bone.It was still attached to the trial, but the plastic around the central metal peg was cracked.No piece broke off inside the patient.There was no harm to the patient, and they were past the point of needing to trial again.The case was completed successfully without complication.The complaint device was discarded.This occurred during use with no patient harm.Additional information has been requested.On 10/3/2023, the sales representative provided the following information via email: there was no case delay reported.No picture was taken as the broken trial was thrown out by spd before they came out of the wash to put the trays back together.
Additional Manufacturer Narrative
Since the complaint device was not returned, a physical evaluation of the device was not performed.However, without the device being returned or any photos provided, the reported event is not confirmed.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17958734
• Report Number: 1220246-2023-08240
• Device Sequence Number: 7044541
• 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): 08/23/2024

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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