MAUDE Adverse Event Report: ARTHREX, INC. AUGMENTED VAULTLOCK, MEDIUM 25R; PROSTHESIS, SHOULDER, CEMENTED

Model Number	AUGMENTED VAULTLOCK, MEDIUM 25R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(60 2025, a distributor reported via email that an ar-9107-02-25r univers vaultlock augmented glenoid, medium 25r had its central peg break off the implant prior to implantation (see attached photo).The issue was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 24-dec-2025: during a total shoulder arthroplasty utilizing an augmented vaultlock glenoid and eclipse system, the central peg of an ar-9107-02-25r univers vaultlock augmented glenoid, medium 25r broke while applying graft with the graft compression tool prior to implantation.All components were retrieved before use.A replacement ar-9107-02-15r univers vaultlock augmented glenoid, medium 15r was implanted instead.The event resulted in an approximate 5¿10 minute delay, with no additional anesthesia administered.Bone quality was assessed as normal, and no adverse patient effects were reported.
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 returned device (if available), photographs, videos, event descriptions, and additional field data, arthrex concluded that the most likely cause of the reported failure was use error, including the application of excessive mechanical force.The complaint allegation was confirmed upon reviewing the customer's attached picture, which shows the device with the central peg broken off.

• Brand Name: AUGMENTED VAULTLOCK, MEDIUM 25R
• Common Device Name: PROSTHESIS, SHOULDER, CEMENTED
• 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: 24036219
• Report Number: 1220246-2026-00138
• Device Sequence Number: 18762374
• Product Code: KWS
• UDI-Device Identifier: 00888867350717
• UDI-Public: (01)00888867350717(11)211001(17)260930(10)M69825R
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K210050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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 Expiration Date: 09/30/2026
• Device Model Number: AUGMENTED VAULTLOCK, MEDIUM 25R
• Device Catalogue Number: AR-9107-02-25R
• Device Lot Number: M69825R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown