MAUDE Adverse Event Report: ARTHREX, INC. AUGMENTED VAULTLOCK, LARGE 15L; PROSTHESIS, SHOULDER, CEMENTED

Model Number	AUGMENTED VAULTLOCK, LARGE 15L
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction

• Brand Name: AUGMENTED VAULTLOCK, LARGE 15L
• 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: 25795785
• Report Number: 1220246-2026-03732
• Device Sequence Number: 12225348
• Product Code: KWS
• UDI-Device Identifier: 00888867350731
• UDI-Public: (01)00888867350731(11)231001(17)280930(10)M80263
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K210050
• 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
• Report Date (Section B): 07/13/2026

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 Model Number: AUGMENTED VAULTLOCK, LARGE 15L
• Device Catalogue Number: AR-9107-03-15L
• Device Lot Number: M80263
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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