MAUDE Adverse Event Report: ARTHREX, INC. 28MM +2 LAT BASEPLATE, MODULAR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number 28MM +2 LAT BASEPLATE, MODULAR

Device Problems Material Separation (1562); Defective Device (2588); Positioning Problem (3009)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2022

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

It was reported on 09/22/2022 by a sales representative via email that an ar-9560-28-2 baseplate and ar-9561-25s modular screw would not compress together with the morse taper using the taper assembly press.This was discovered during a case with no patient harm.Per facility: " it was confirmed that the compression line between maximum and minimum was achieved but up inserting the implant the two pieces became disassembled.We were able to retrieve both parts safely without harming the patient.We then assembled two new parts, same sizes, and in the same fashion without issues.".

Manufacturer Narrative

Complaint is confirmed.One unpackaged ar-9560-28-2 - 28mm +2 lat baseplate, modular serial/batch number (b)(6), was received for investigation.Functional testing found that the device does not attach to the returned ar-9561-25s - 25mm central screw, modular.Additionally, the visual evaluation found that the baseplate connector hex was damaged, revealing cracks and nicks.Complaint use error.

• Brand Name: 28MM +2 LAT BASEPLATE, MODULAR
• 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: 15571772
• MDR Text Key: 306821438
• Report Number: 1220246-2022-05601
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867296503
• UDI-Public: 00888867296503
• 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,Followup
• Report Date: 03/10/2023

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: 28MM +2 LAT BASEPLATE, MODULAR
• Device Catalogue Number: AR-9560-28-2
• Device Lot Number: 13289794
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/10/2022
• Supplement Dates Manufacturer Received: 09/23/2022
• Supplement Dates FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1