MAUDE Adverse Event Report: ARTHREX, INC. CR PLUS TIB BEARING, VIT E, SZ 1, 9MM; KNEE PROSTHESIS PAT/FEM/TIB

Model Number	CR PLUS TIB BEARING, VIT E, SZ 1, 9MM
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that poly would not seat onto the baseplate correctly.The surgeon tried it with 2 implants with different lot numbers multiple times and neither one worked.The surgeon used a size 10 and that implant snapped into place, without issue.Additional information 4/13/2021 it was reported that during a knee procedure, the ar-523-a109, poly would not seat onto the baseplate correctly.The surgeon tried it with 2 implants with different lot numbers multiple times and neither one worked.The case was completed using ar-523-a210.
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 user error due to misaligned insertion.

• Brand Name: CR PLUS TIB BEARING, VIT E, SZ 1, 9MM
• Common Device Name: KNEE PROSTHESIS PAT/FEM/TIB
• 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: 19289005
• Report Number: 1220246-2024-03119
• Device Sequence Number: 15615727
• Product Code: MBH
• UDI-Device Identifier: 00888867231078
• UDI-Public: 00888867231078
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K171365
• 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): 05/10/2024

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: 05/31/2025
• Device Model Number: CR PLUS TIB BEARING, VIT E, SZ 1, 9MM
• Device Catalogue Number: AR-523-A109
• Device Lot Number: 579202224
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2020
• 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