MAUDE Adverse Event Report: ARTHREX, INC. MODULAR POST, 25MM; SHOULDR PROSTH, REVERSE CONFIG

Model Number	MODULAR POST, 25MM
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
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.Visual inspection shows a gap between the two connected parts.Devices do not disengage.Per surgical guide for ar-9580-2410 "there is a hex feature that must be aligned between the components for taper to engage." the hex feature was not appropriately aligned causing the failure.Cause of the failure has been determined to be user error.Complaint was confirmed.
Event or Problem Description
On 10/27/2022, it was reported by a sales representative via phone that a ar-9580-2410 augmented base plate, and a ar-9582-25 modular post for augmented mgs baseplate are not locking.This occurred on 10/25/2022 during a revers total shoulder arthroplasty when the 2 devices would not connect together.Another device of each were opened, and worked accordingly.The case was completed, with no patient effect reported.

• Brand Name: MODULAR POST, 25MM
• 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: 19267445
• Report Number: 1220246-2024-02941
• Device Sequence Number: 20678387
• Product Code: PHX
• UDI-Device Identifier: 00888867341845
• UDI-Public: 00888867341845
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K193372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2024

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: MODULAR POST, 25MM
• Device Catalogue Number: AR-9582-25
• Device Lot Number: 1230942206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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