MAUDE Adverse Event Report: ARTHREX, INC. 36 +6 / 33 COMBO HUMERAL INSERT; SHOULDR PROSTH, REVERSE CONFIG

Model Number	36 +6 / 33 COMBO HUMERAL INSERT
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/03/2023
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
On 10/4/2023, it was reported by a sales representative via phone that an ar-9503-3633-6 univers revers modular glenoid system combo humeral insert and an ar-9503-3336-6 combination humeral insert would not sit properly.The surgeon had to use an ar-9562-36nl univers revers non-locking peripheral screw, to remove the humeral insert.The case was delayed for about ten minutes, and it was completed using an ar-9504-06 humeral spacer and an ar-9503-3336-3 combination humeral insert.This was discovered during an rts procedure on (b)(6) 2023.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error due to mishandling.

• Brand Name: 36 +6 / 33 COMBO HUMERAL INSERT
• 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: emily shafer ; 8009337001
• MDR Report Key: 18039120
• Report Number: 1220246-2023-08464
• Device Sequence Number: 7429215
• Product Code: PHX
• UDI-Device Identifier: 00888867296602
• UDI-Public: 00888867296602
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/10/2025

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: 09/30/2026
• Device Model Number: 36 +6 / 33 COMBO HUMERAL INSERT
• Device Catalogue Number: AR-9503-3633-6
• Device Lot Number: 21.01810
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown