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	09/09/2024
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 09/10/2024, it was reported by a sales representative via sems- (b)(4) that an ar-9236-01pp univers vaultlock¿ glenoid trial had the central peg snap off during trailing.There was no disruption or delay in surgery.The broken piece was retrieved from the patient.The case was carried on and completed successfully.This was discovered during an atsa procedure on (b)(6) 2024.
Event or Problem Description
Additional information was received on 09/12/2024: the case was completed without incident, trialing had already occurred and was verified.The instrument did not break during insertion, but rather extraction.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged, ar-9236-01pp, univers vaultlock¿ glenoid trial, serial/batch number (b)(6), was received for investigation.Visual evaluation found that the device has a broken center peg.Additionally, the device had chips along the edges and a crack down the back of the device.No fragments were returned for evaluation.No functional testing was performed, as part is damaged.The most likely cause for the reported failure can be attributed to use error of the device due to prying/leveraging the device during use.

• 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: 20259135
• Report Number: 1220246-2024-07754
• Device Sequence Number: 18126326
• Product Code: KWS
• UDI-Device Identifier: 00888867250673
• UDI-Public: 00888867250673
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 02/03/2025

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: 1027262045
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 09/12/2024; 01/07/2025
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 09/27/2024; 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2020
• 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