MAUDE Adverse Event Report: ARTHREX, INC. 24MM BASEPLATE, 20° FULL AUG, +2 LAT, ST; SHOULDR PROSTH, REVERSE CONFIG

Model Number	24MM BASEPLATE, 20° FULL AUG, +2 LAT, ST
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 it was reported by a sales representative via email that ar-9582-30 modular post and an ar-9580-2420-2s augmented baseplate did not lock.Surgeon attempted to implant them multiple times but it would not seat.This was discovered during a reverse total shoulder replacement procedure on (b)(6) 2022.Additional information received on (b)(6) 2022: surgeon removed both the baseplate and post from the patient and used an ar-9580-2410-2 baseplate and ar-9582-30 modular post to complete the case without further issues.Nothing broke off inside the patient.
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.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 wear and tear.

• Brand Name: 24MM BASEPLATE, 20° FULL AUG, +2 LAT, ST
• 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: 19483172
• Report Number: 1220246-2024-05167
• Device Sequence Number: 8139369
• Product Code: PHX
• UDI-Device Identifier: 00888867352117
• UDI-Public: 00888867352117
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K211074
• 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 BASEPLATE, 20° FULL AUG, +2 LAT, ST
• Device Catalogue Number: AR-9580-2420-2S
• Device Lot Number: 1148442135
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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