MAUDE Adverse Event Report: ARTHREX, INC. GLENOID, PE WITH PEG, LARGE; PROSTHESIS, SHOULDER, CEMENTED

Model Number	GLENOID, PE WITH PEG, LARGE
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
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.Complaint not confirmed, the device is not damaged and relevant critical dimensions were found to meet specifications.
Event or Problem Description
On 10/28/2021, it was reported by a sales representative via phone that an ar-9105-03 glenoid didn't fit and the ar-9561-20p central post would not engage.This was discovered during use in a reverse arthroplasty on (b)(6) 2021.The case was completed by using a new ar-9105-03 and ar-9561-20p.

• Brand Name: GLENOID, PE WITH PEG, LARGE
• Common Device Name: PROSTHESIS, SHOULDER, CEMENTED
• 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: 19212475
• Report Number: 1220246-2024-02608
• Device Sequence Number: 6903803
• Product Code: KWS
• UDI-Device Identifier: 00888867057333
• UDI-Public: 00888867057333
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K083435
• 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): 04/30/2024

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: 10/31/2021
• Device Model Number: GLENOID, PE WITH PEG, LARGE
• Device Catalogue Number: AR-9105-03
• Device Lot Number: 113601630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2016
• 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