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	01/07/2025
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 01/10/2025, a sales representative reported via (b)(4) that an ar-9236-03pp univers vaultlock¿ glenoid trial, large, had the center of the peg break off during trialing.It was retrieved easily from the center hole with a hemostat and did not cause a case delay.This was discovered during a procedure, with no reported patient harm.Additional information was received on 01/13/2025: the trial confirmed the correct placement and broke upon removal.The case was completed.This was discovered during an tsa procedure on (b)(6)2025.
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 concluded that the most likely cause for the reported failure can be attributed to user error, including applying excessive force during use.The complaint allegation was not confirmed, and no evidence of the failure was received.

• 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: 21312962
• Report Number: 1220246-2025-00194
• Device Sequence Number: 20893992
• Product Code: KWS
• UDI-Device Identifier: 00888867250697
• UDI-Public: (01)00888867250697(11)210827(10)S264TG000
• 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): 09/04/2025

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: S264TG000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2021
• 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