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	12/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/30/2024, a sales representative reported via (b)(4) that an ar-9236-03pp univers vaultlock¿ glenoid trial, ar-9231-vl-03 univers vaultlock glenoid drill guide, and ar-9215-1-03 universal quick connect handle broke (see photos).No further information was provided.This was discovered during use, with no reported patient harm.Additional information was received on 01/07/2024: this was discovered during a anatomic total shoulder arthroplasty procedure on (b)(6) 2024.The case was completed successfully with no harm to the patient.There was no case delay reported and no adverse effects on the patient.Additional information was received on 01/10/2025: the ar-9236-03pp univers vaultlock¿ glenoid trial had the central post break off in the patient and was retrieved.The ar-9215-1-03 universal quick connect handle had the handle tip break off into the glenoid drill guide.After further investigation, ar-9231-vl-03 univers vaultlock glenoid drill guide had no damage found.The failure occurred during the insertion of the ar-9236-03pp univers vaultlock¿ glenoid trial.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is the possible wear and tear of the device.The device was manufactured in 2016.The complaint allegation could not be confirmed.The customer provided a photo of part ar-9236-03pp, batch 1027261630, which does not show any visible breakage.However, the angle of the photo does not clearly reveal potential damage to the device.

• 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: 21218854
• Report Number: 1220246-2025-00061
• Device Sequence Number: 8640281
• Product Code: KWS
• UDI-Device Identifier: 00888867250697
• UDI-Public: (01)00888867250697(11)160727(10)1027261630
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/10/2025

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, LARGE
• Device Catalogue Number: AR-9236-03PP
• Device Lot Number: 1027261630
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2016
• 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