MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS VAULTLOCK GLENOID TRIAL, MEDIUM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNIVERS VAULTLOCK GLENOID TRIAL, MEDIUM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
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 10/29/2024, an arthrex subsidiary employee reported via (b)(4) that an ar-9236-02pp univers vaultlock¿ glenoid trial peg broke in two pieces when trying to remove the trial from the bone with no excessive force used.The broken pieces were removed from the patient, and the case was continued and completed.This event did not affect the patient.This was discovered during a left total shoulder arthroplasty procedure on (b)(6) 2024, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Visual evaluation of the customer-provided pictures noted an ar-9236-02pp univers vaultlock¿ glenoid trial peg broke in two pieces.Refer to attachments.The complaint allegation is confirmed based on the customer-provided pictures.Based on the information provided, 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 improper bone preparation and/or prying/leveraging during use.

• Brand Name: UNIVERS VAULTLOCK GLENOID TRIAL, MEDIUM
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 20652486
• Report Number: 1220246-2024-08502
• Device Sequence Number: 20507504
• Product Code: KWS
• UDI-Device Identifier: 00888867250680
• UDI-Public: (01)00888867250680(11)230629(10)S516GT000
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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 TRIAL, MEDIUM
• Device Catalogue Number: AR-9236-02PP
• Device Lot Number: S516GT000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown