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

Model Number	UNIVERS VAULTLOCK GLENOID TRIAL, LARGE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 13-may-2026, it was reported by a sales representative via (b)(4) that an ar-9236-03pp vaultlock glenoid central peg broke off in the patient.This occurred during use in a case with no patient impact.All fragments were retrieved from within the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: UNIVERS VAULTLOCK GLENOID TRIAL, LARGE
• 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: 25361353
• Report Number: 1220246-2026-03139
• Device Sequence Number: 9966886
• Product Code: KWS
• UDI-Device Identifier: 00888867250697
• UDI-Public: 00888867250697
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 07/06/2026

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, LARGE
• Device Catalogue Number: AR-9236-03PP
• Device Lot Number: NB
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown