MAUDE Adverse Event Report: ARTHREX, INC. 5.5X20MM PERIPHERAL SCREW, LOCKING; SHOULDR PROSTH, REVERSE CONFIG

Model Number 5.5X20MM PERIPHERAL SCREW, LOCKING

Device Problem Defective Device (2588)

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

Event Date 02/29/2024

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 02/29/2024, it was reported by a sales representative via e-mail that an ar-9563-20 univers revers¿ modular glenoid system locking threads were defective.This occurred during a procedure where another locking screw was used in its place, and there were no adverse effects.

• Brand Name: 5.5X20MM PERIPHERAL SCREW, LOCKING
• Type of Device: SHOULDR PROSTH, REVERSE CONFIG
• 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: 18835353
• MDR Text Key: 336864004
• Report Number: 1220246-2024-01288
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867296824
• UDI-Public: 00888867296824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173900
• 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: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5.5X20MM PERIPHERAL SCREW, LOCKING
• Device Catalogue Number: AR-9563-20
• Device Lot Number: 15162312
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1