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

Model Number	28MM +2 LAT BASEPLATE, MODULAR
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.".
Additional 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
• Common Device Name: 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
• Report Number: 1220246-2022-05601
• Device Sequence Number: 14179638
• Product Code: PHX
• UDI-Device Identifier: 00888867296503
• UDI-Public: 00888867296503
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 10/10/2022
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown