MAUDE Adverse Event Report: ARTHREX, INC. 24MM BASEPLATE, 20° FULL AUG, OB; SHOULDR PROSTH, REVERSE CONFIG

Model Number 24MM BASEPLATE, 20° FULL AUG, OB

Device Problem Defective Device (2588)

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

Event Date 09/15/2022

Event Type  malfunction  

Manufacturer Narrative

This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Visual inspection shows a gap between the two connected parts.Devices do not disengage.Per surgical guide for ar-9580-2420 "there is a hex feature that must be aligned between the components for taper to engage." the hex feature was not appropriately aligned causing the failure.Cause of the failure has been determined to be user error.Complaint was confirmed.

Event Description

On 9/16/2022, it was reported by a sales representative via phone that an ar-9580-2420 24mm baseplate and an ar-9582-25 modular post had an issue during a reverse total shoulder arthroplasty on(b)(6^) 2022.The baseplate was prepared with the modular post on the back table, with the desired length, and then put into the patient.It was noticed that during the screw insertion, the baseplate rotated slightly and was loose inside the patient.The screws were taken out and the baseplate with the modular post was taken out of the patient.A different implant was used, part and lot number unknown, and a longer post, part, and lot number unknown, were used to complete the procedure successfully no impact to the patient.Nothing broke inside the patient.The complaint devices were available for return.

• Brand Name: 24MM BASEPLATE, 20° FULL AUG, OB
• 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: 19071127
• MDR Text Key: 339715976
• Report Number: 1220246-2024-01909
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867341647
• UDI-Public: 00888867341647
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193372
• 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: 04/09/2024

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: 24MM BASEPLATE, 20° FULL AUG, OB
• Device Catalogue Number: AR-9580-2420
• Device Lot Number: 1191012146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2022
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1