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

Model Number COMBINATION HUMERAL INSERT 33+6 / 36

Device Problem Fitting Problem (2183)

Patient Problem Insufficient Information (4580)

Event Date 10/03/2023

Event Type  malfunction  

Event Description

On (b)(6) 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.

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.

• Brand Name: COMBINATION HUMERAL INSERT 33+6 / 36
• Type of Device: 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: 18040308
• MDR Text Key: 326980521
• Report Number: 1220246-2023-08468
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00888867406827
• UDI-Public: 00888867406827
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221232
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/31/2023

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: COMBINATION HUMERAL INSERT 33+6 / 36
• Device Catalogue Number: AR-9503-3336-6
• Device Lot Number: 22.00559
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1