MAUDE Adverse Event Report: ARTHREX, INC. 24MM +2 LAT BASEPLATE, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

Model Number	24MM +2 LAT BASEPLATE, MODULAR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 1/31/2023 it was reported by a sales representative via phone that an ar-9560-24-2 baseplate and an ar-9561-35s central screw had an issue.During a reverse total shoulder procedure on (b)(6) 2023, when the surgeon was inserting the baseplate with the screw inside the patient, the screw broke off the baseplate into the glenoid.Both devices were removed from the patient, and all fragments were retrieved.Another baseplate ar-9560-24-4 with lot number 15030027 and another screw ar-9561-30s with lot # 14977751 was used to complete the procedure successfully with no impact to the patient.Both devices are available for return.
Additional 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.Complaint is confirmed.Upon visual evaluation, it was noted that the six edges of the hex are damaged.Possible failure could be caused by excessive force or improper placement of the device.The most likely cause for the reported failure can be attributed to user-applied excessive mechanical forces.

• Brand Name: 24MM +2 LAT 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: jared engle ; 8009337001
• MDR Report Key: 19483199
• Report Number: 1220246-2024-05171
• Device Sequence Number: 7905957
• Product Code: PHX
• UDI-Device Identifier: 00888867296497
• UDI-Public: 00888867296497
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2024

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
• Operator of Device: Health Professional
• Device Model Number: 24MM +2 LAT BASEPLATE, MODULAR
• Device Catalogue Number: AR-9560-24-2
• Device Lot Number: 15037954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2022
• 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