MAUDE Adverse Event Report: ARTHREX, INC. IBAL TKA TIB BRNG TRL CR + SZ 2,8MM; ORTHOPAEDIC TEMPLATE

Model Number	IBAL TKA TIB BRNG TRL CR + SZ 2,8MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
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 confirmed.Visual evaluation showed the device has a crack at the middle of the device.Crack runs front the edge to the middle hole at the front of the device.The back of the device shows dents around it.Based off the information provided, the most likely cause is user apply mechanical forces.
Event or Problem Description
It was reported after a procedure the ar-603-a208 was discovered cracked in the middle.Case went according to plan without incident.Additional information 6/15/2021 it was reported after a tka procedure the ar-603-a208 was discovered cracked in the middle on articular side.Case went according to plan without incident.

• Brand Name: IBAL TKA TIB BRNG TRL CR + SZ 2,8MM
• Common Device Name: ORTHOPAEDIC TEMPLATE
• 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: 19559493
• Report Number: 1220246-2024-05954
• Device Sequence Number: 15135978
• Product Code: HWT
• UDI-Device Identifier: 00888867112452
• UDI-Public: 00888867112452
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

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: IBAL TKA TIB BRNG TRL CR + SZ 2,8MM
• Device Catalogue Number: AR-603-A208
• Device Lot Number: 113601709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown