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 Problems Break (1069); Device Damaged by Another Device (2915)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2022

Event Type  malfunction  

Event Description

On 08/18/2022, it was reported by a sales representative via sems that an ar-9236-02pp univers vaultlock¿ glenoid trial, medium, an ar-9215-1-02 glenoid drill guide handle, long and an ar-9231-02pp drill guide, univers vaultlock¿ glenoid, medium had an issue during a total shoulder arthroplasty procedure on (b)(6) 2022.It was a tough anatomic shoulder arthroplasty case with tight exposure.When removing the medium vaultlock drill guide, the threaded tip of the drill guide handle broke off inside the drill guide, rendering both instruments defective.Later when removing the medium vaultlock trial, the central peg broke off.The piece broke off inside the patient, and was retrieved from the patient.The case was completed successfully.The ar-9236-02pp was not available for return as it was disposed of by the hospital staff.This was discovered during use with no impact to the patient.

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.

• 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: 15362489
• MDR Text Key: 305703576
• Report Number: 1220246-2022-05450
• 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: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2022
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1