MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS VAULTLOCK GLENOID, MEDIUM; PROSTHESIS, SHOULDER, CEMENTED

Model Number	UNIVERS VAULTLOCK GLENOID, MEDIUM
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint not confirmed.Upon visual inspection, it was noted that the pegs were damaged.No other problems were noted with the device.The lengths of all pegs were measured and found to meet drawing specifications.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation.
Event or Problem Description
On 6/20/2022, it was reported by a sales representative via email that an ar-9106-02 univers vaultlock glenoid did not fully seat.The humeral head component was removed with the extraction tool.The cage screw and trunion were also unscrewed and removed.The 3 inferior 4mm glenoid holes were re-drilled, both glenoid broaches were used, a trial component was placed and removed and a new vaultlock glenoid inserted.Autologous bone from the humeral head was placed in the area where the cage screw was removed and compacted.The trunion and cage screw were inserted with excellent purchase and the shoulder was reduced without complications.This was discovered during an eclipse total shoulder arthroplasty on (b)(6) 2022.Additional information requested.

• Brand Name: UNIVERS VAULTLOCK GLENOID, MEDIUM
• 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: 19247159
• Report Number: 1220246-2024-02790
• Device Sequence Number: 12564350
• Product Code: KWS
• UDI-Device Identifier: 00888867239326
• UDI-Public: 00888867239326
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2024

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, MEDIUM
• Device Catalogue Number: AR-9106-02
• Device Lot Number: 1027262117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown