MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS VAULTLOCK GLENOID TRIAL, SMALL; ORTHOPEDIC MANUAL SURG INSTR

Model Number UNIVERS VAULTLOCK GLENOID TRIAL, SMALL

Device Problem Break (1069)

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

Event Date 02/14/2024

Event Type  malfunction  

Event Description

On (b)(6) 2024, it was reported by a sales representative via sems (b)(4) that an ar-9236-01pp glenoid tray peg broke off.This occurred during use in a case with no patient effect."the central peg broke when the surgeon was removing the trial from the patient's prepped glenoid (so the patient was involved).The central peg was easily removed from the patient after it broke off.".

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: UNIVERS VAULTLOCK GLENOID TRIAL, SMALL
• Type of Device: ORTHOPEDIC MANUAL SURG INSTR
• 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: jared engle ; 8009337001
• MDR Report Key: 18856341
• MDR Text Key: 337110066
• Report Number: 1220246-2024-01335
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1