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

Model Number UNIVERS VAULTLOCK GLENOID TRIAL, MEDIUM

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 01/03/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, it was reported by a sales representative via sems that the top peg of an ar-9236-02pp glenoid trial cracked off.This was discovered during use in a procedure.No patient affect reported.

Manufacturer Narrative

Complaint confirmed.One unpackaged ar-9236-02pp trial was received for investigation.Visual inspection identified that the superior peg broke off the body of the trial.The fragment was not returned for assessment.The central peg remained intact, although a crack was visualized starting from the base of the trial and traveling over halfway up the length of the peg.Chipping was present along the inner diameter of the trial body.This event is most likely the result of damage incurred during the removal process.

• Brand Name: UNIVERS VAULTLOCK GLENOID TRIAL, MEDIUM
• 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: 13333548
• MDR Text Key: 287179026
• Report Number: 1220246-2022-04315
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888867250680
• UDI-Public: 00888867250680
• 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: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• 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, MEDIUM
• Device Catalogue Number: AR-9236-02PP
• Device Lot Number: 1027262101
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1