MAUDE Adverse Event Report: ARTHREX, INC. IBAL TKA TIB BRNG TRL CR + SZ 6,8MM; ORTHOPAEDIC TEMPLATE

Model Number	IBAL TKA TIB BRNG TRL CR + SZ 6,8MM
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/07/2021
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 almost the middle hole at the front of the device.The side of the devices there are also scratch.The most likely cause for the reported failure can be attributed to user-applied excessive mechanical forces.
Event or Problem Description
On 12/8/2021, it was reported by a sales representative via sems that an ar-603-a608 tibial bearing cracked.This was discovered during a tka procedure on (b)(6) 2021.Surgeon used thicker device to complete case without further issues.

• Brand Name: IBAL TKA TIB BRNG TRL CR + SZ 6,8MM
• 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: 19398865
• Report Number: 1220246-2024-03965
• Device Sequence Number: 15403811
• Product Code: HWT
• UDI-Device Identifier: 00888867112773
• UDI-Public: 00888867112773
• 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): 05/26/2024

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 6,8MM
• Device Catalogue Number: AR-603-A608
• Device Lot Number: 113601712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 05/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2017
• 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