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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/29/2025, it was reported by a sales representative via (b)(4) that an ar-9236-01pp glenoid trial broke.This occurred during use in a case with no patient effect.All fragments removed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-9236-01pp, batch 1027265015, was received for investigation.Visual inspection revealed a fractured peg on the device.Functional testing was not performed due to the device¿s damage.The most likely cause for the reported failure can be attributed to excessive user-applied mechanical forces.Refer to the investigation photos.The complaint allegation is confirmed.

• 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: 23097098
• Report Number: 1220246-2025-03967
• Device Sequence Number: 15798539
• Product Code: KWS
• UDI-Device Identifier: 00888867250673
• UDI-Public: (01)00888867250673(11)250411(10)200741000
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 12/05/2025

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: 200741000
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown