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

Model Number	42/28 GLENOSPHERE
Medical Device Problem Code	Environmental Particulates (2930)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Event or Problem 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.(b)(6)2023: the device was opened when patient was already under anaesthesia.No third device was available.
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
Update swit 25-jul-2023: lot 19.00606 was implanted and remains inside the patient.
Additional Manufacturer Narrative
Additional information: d4, d9, g3, h3, h6.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to a manufacturing issue; however, due to the device not being returned, we are unable to confirm the reported event.

• Brand Name: 42/28 GLENOSPHERE
• 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: 17380040
• Report Number: 1220246-2023-07296
• Device Sequence Number: 5929136
• Product Code: PHX
• UDI-Device Identifier: 00888867295803
• UDI-Public: 00888867295803
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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 Expiration Date: 04/30/2024
• Device Model Number: 42/28 GLENOSPHERE
• Device Catalogue Number: AR-9564-2842
• Device Lot Number: 19.00606
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• 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