MAUDE Adverse Event Report: ARTHREX, INC. UNI GLENOID-PERIPHERAL LOCK SCRW; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number UNI GLENOID-PERIPHERAL LOCK SCRW

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/09/2022

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 12/15/2022 it was reported by a sales representative by email that a ar-9145-48 universal glenoid locking screw broke when being driven into a glenoid.This was discovered during an eclipse tsa w/ convertible universal glenoid on (b)(6) 2022.The tip was removed, but the remainder of the screw was left in the patient.

• Brand Name: UNI GLENOID-PERIPHERAL LOCK SCRW
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 16086905
• MDR Text Key: 308505291
• Report Number: 1220246-2023-06016
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867057753
• UDI-Public: 00888867057753
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142863
• 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: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: UNI GLENOID-PERIPHERAL LOCK SCRW
• Device Catalogue Number: AR-9145-48
• Device Lot Number: 170167313
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2022
• Date Device Manufactured: 04/01/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1