MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS VAULTLOCK GLENOID, LARGE; PROSTHESIS, SHOULDER, CEMENTED

Model Number	UNIVERS VAULTLOCK GLENOID, LARGE
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 11/04/2024, it was reported by a sales representative via (b)(4) that an ar-9106-03 univers vaultlock glenoid, large had the peg damaged during implantation.This was discovered during a procedure, with no reported patient harm.
Event or Problem Description
Additional information was received on 12/19/2024: all fragments were removed from the patient.There was a case delay of thirty minutes while waiting for a second implant.It is unknown if additional anesthesia was administered to the patient.The case was completed with a new implant with no complications.No adverse effects on the patient reported.This was discovered during a tsa procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.
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 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 improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: UNIVERS VAULTLOCK GLENOID, LARGE
• Common Device Name: PROSTHESIS, SHOULDER, CEMENTED
• 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: 20796889
• Report Number: 1220246-2024-08656
• Device Sequence Number: 7809223
• Product Code: KWS
• UDI-Device Identifier: 00888867239333
• UDI-Public: (01)00888867239333(11)220101(17)261231(10)1027262120
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K161108
• 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,Followup
• Report Date (Section B): 07/08/2025

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: UNIVERS VAULTLOCK GLENOID, LARGE
• Device Catalogue Number: AR-9106-03
• Device Lot Number: 1027262120
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 12/19/2024; 06/12/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/15/2025; 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2022
• 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