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

Model Number	UNIVERS VAULTLOCK GLENOID TRIAL, SMALL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/30/2025
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 (b)(6) 2025, a sales representative reported via (b)(4) that an ar-9236-01pp univers vaultlock¿ glenoid trial broke.This occurred during a syracuse when the surgeon was trying to insert with forceps.There was no excessive force used.The center post was still hanging on by a thread so the doctor just pulled it off and reinserted a trial with a peg and keel.There were no issues, and no added time.¿.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.He complaint allegation was confirmed.One unpackaged ar-9236-01pp serial/batch number (b)(6) was received for investigation.No functional testing was performed; part is broken.Upon visual evaluation, the middle/center pole was noted to be broken off.Nicks, marks, and cuts on the device material were also observed.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.Device manufacturing date: 10/05/2021.

• Brand Name: UNIVERS VAULTLOCK GLENOID TRIAL, SMALL
• 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: 21399312
• Report Number: 1220246-2025-00501
• Device Sequence Number: 9576257
• Product Code: KWS
• UDI-Device Identifier: 00888867250673
• UDI-Public: (01)00888867250673(11)211005(10)1027262110
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Date (Section B): 06/02/2025

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, SMALL
• Device Catalogue Number: AR-9236-01PP
• Device Lot Number: 1027262110
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown