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

Model Number UNIVERS VAULTLOCK GLENOID TRIAL, SMALL

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 09/22/2022

Event Type  malfunction  

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 Description

On 09/23/2022, it was reported by a sales representative via sems that a ar-9236-01pp glenoid trials center peg broke.This occurred on (b)(6) 2022 during an unknown case, when removing the trial from the glenoid.The center peg was retrieved, and there was not patient effect reported.

• Brand Name: UNIVERS VAULTLOCK GLENOID TRIAL, SMALL
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER 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: vik bajnath ; 8009337001
• MDR Report Key: 15614900
• MDR Text Key: 306440081
• Report Number: 1220246-2022-05609
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888867250673
• UDI-Public: 00888867250673
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNIVERS VAULTLOCK GLENOID TRIAL, SMALL
• Device Catalogue Number: AR-9236-01PP
• Device Lot Number: 1027265015
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2022
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1