MAUDE Adverse Event Report: ARTHREX, INC. 42/28 GLENOSPHERE; SHOULDR PROSTH, REVERSE CONFIG

Model Number 42/28 GLENOSPHERE

Device Problem Environmental Particulates (2930)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/27/2023

Event Type  malfunction  

Event Description

It was reported that during an inverse prothesis surgery the glenosphere shows dust particles after opening the packaging.One glenosphere was discarded, the second was implanted.There was no harm for patient, operator or third party.The surgery was finished successfully.It was not necessary to switch the surgical technique or do a second surgery.Update swit (b)(6)2023: the device was opened when patient was already under anaesthesia.No third device was available.

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: 42/28 GLENOSPHERE
• 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: 17380010
• MDR Text Key: 319746263
• Report Number: 1220246-2023-07295
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867295803
• UDI-Public: 00888867295803
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K173900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/24/2023

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 Expiration Date: 05/31/2024
• Device Model Number: 42/28 GLENOSPHERE
• Device Catalogue Number: AR-9564-2842
• Device Lot Number: 19.00606
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/24/2023
• Date Device Manufactured: 06/01/2019
• 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