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	05/03/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported one of the tabs broke off when it was being impacted.This was discovered after that part of the procedure was completed.The tab was retrieved and the case was completed with no further issues.The patient is fine to date.
Additional Manufacturer Narrative
Complaint confirmed.Visual inspection identified that the central post and one of the tabs across the trial had broken off.The fragments generated during the event were not returned for analysis.The observed condition is most likely the result of excessive force used as the device was impacted.A review of the device history record with the complaint batch identified that the trial was manufactured in 2016, additionally.

• 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: 11871684
• Report Number: 1220246-2021-03125
• Device Sequence Number: 4269465
• Product Code: KWS
• UDI-Device Identifier: 00888867250703
• UDI-Public: 00888867250703
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 06/09/2021

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, X-LARGE
• Device Catalogue Number: AR-9236-04PP
• Device Lot Number: 1027261635
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 06/09/2021
• Patient Sequence Number: 1