MAUDE Adverse Event Report: ARTHREX, INC. 24MM BASEPLATE, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

Model Number	24MM BASEPLATE, MODULAR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 3/24/2023, it was reported by a sales representative via phone that an ar-9560-24 24mm baseplate, modular had an issue.During a reverse shoulder arthroplasty procedure on (b)(6) 2023.When the surgeon tried to use the baseplate, the screws separated/broke off from the baseplate inside the patient, and the implant could not be used.The screws were solvable.All fragments were removed from the patient, and a new baseplate with lot number 14996909 was opened and used to complete the procedure successfully with no impact to the patient.
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.
Additional Manufacturer Narrative
Complaint is confirmed.Upon visual evaluation, it was noted that the device has damage around the hex edges.The most probable cause of this failure can be the wrong assembly with other implants designed specifically for use with this system.However, the other components were not returned for investigation.The cause remains undetermined.

• Brand Name: 24MM BASEPLATE, MODULAR
• Common Device Name: 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: vik bajnath ; 8009337001
• MDR Report Key: 16785336
• Report Number: 1220246-2023-06570
• Device Sequence Number: 17562626
• Product Code: PHX
• UDI-Device Identifier: 00888867296411
• UDI-Public: 00888867296411
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

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 Model Number: 24MM BASEPLATE, MODULAR
• Device Catalogue Number: AR-9560-24
• Device Lot Number: 15030198
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown