MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, SMALL IMPACTOR; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBALANCE TKA, SMALL IMPACTOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 11/14/2023, it was reported by an arthrex employee via sems-06401414 that an ar-613-98 ibalance¿ tkas plastic from the fish mouth snapped off.This occurred during a total knee procedure where nothing entered the patient.The broken piece fell to the floor.The case was completed with a new tray.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint is confirmed.Visual evaluation noted that the notch/bearing impactor was broken, and the key seat geometry was damaged around the edges.Functional testing was not performed due to damage to the device.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• Brand Name: IBALANCE TKA, SMALL IMPACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 18292619
• Report Number: 1220246-2023-09304
• Device Sequence Number: 6696642
• Product Code: LXH
• UDI-Device Identifier: 00888867116955
• UDI-Public: 00888867116955
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 12/02/2024

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: IBALANCE TKA, SMALL IMPACTOR
• Device Catalogue Number: AR-613-98
• Device Lot Number: 113601639
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown