MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS VAULTLOCK GLENOID TRIAL, X-LARGE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UNIVERS VAULTLOCK GLENOID TRIAL, X-LARGE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported during an apex total shoulder repair the ar-9236-04pp center peg broke when trying to remove.All pieces were retrieved with no issues to case.Ar-9231-20 was not working on broach and version rod angles were off.These items were replaced and the case was completed and the patient is fine to date.
Additional Manufacturer Narrative
Complaint confirmed, the central peg broke off flush with the rest of the device.The cause of the event is undetermined, however a likely cause is user-applied mechanical forces.

• Brand Name: UNIVERS VAULTLOCK GLENOID TRIAL, X-LARGE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11437148
• Report Number: 1220246-2021-02694
• Device Sequence Number: 14745019
• Product Code: KWS
• UDI-Device Identifier: 00888867250703
• UDI-Public: 00888867250703
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: UNIVERS VAULTLOCK GLENOID TRIAL, X-LARGE
• Device Catalogue Number: AR-9236-04PP
• Device Lot Number: 1027261635
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 03/09/2021
• Patient Sequence Number: 1