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

Model Number	UNIVERS VAULTLOCK GLENOID TRIAL, MEDIUM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/04/2024, a sales representative reported via sems-(b)(4) that (qty.(b)(4)) of an ar-9236-02pp univers vaultlock¿ glenoid trial, medium, was broken.The case was completed with a backup trial from another set available without adverse effects on the patient.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
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.Complaint allegation is confirmed.One unpackaged ar-9236-02pp medium univers vaultlock¿ glenoid trial batch number: 189622000 was received for investigation.Visual evaluation of the returned device noted that the central peg of the device had broken off.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging from repeated usage/reprocessing.Manufactured date: 12-jan-2022.

• Brand Name: UNIVERS VAULTLOCK GLENOID TRIAL, MEDIUM
• 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: 21048854
• Report Number: 1220246-2024-09161
• Device Sequence Number: 3409160
• Product Code: KWS
• UDI-Device Identifier: 00888867250680
• UDI-Public: (01)00888867250680(11)220112(10)189622000
• 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): 03/19/2025

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, MEDIUM
• Device Catalogue Number: AR-9236-02PP
• Device Lot Number: 189622000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown