MAUDE Adverse Event Report: ARTHREX, INC. KEEL PUNCH, SIZE 8-10, IBALANCE TKA; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	KEEL PUNCH, SIZE 8-10, IBALANCE TKA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/09/2023
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 03/09/2023, it was reported by a sales representative via sems that an ar-623-7 ibalance® tka metal piece broke off into an impaction handle.This occurred during a tka case on (b)(6) 2023.There was no additional information provided.Additional information is requested.
Additional Manufacturer Narrative
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used during use.
Event or Problem Description
Additional information was provided on 03/13/2023 where it was reported by a sales representative the device did break while inside the patient.When the doctor went to slap hammer the piece out, the top part broke off.No fragments were inside of the patient, and the broken piece was stuck in the underside of the slap hammer.The patient had osteoporotic bone, and the surgeon used a set of pliers to pull the rest of the tibial punch out.

• Brand Name: KEEL PUNCH, SIZE 8-10, IBALANCE TKA
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16618569
• Report Number: 1220246-2023-06499
• Device Sequence Number: 12565607
• Product Code: LXH
• UDI-Device Identifier: 00888867198388
• UDI-Public: 00888867198388
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/02/2024

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: KEEL PUNCH, SIZE 8-10, IBALANCE TKA
• Device Catalogue Number: AR-623-7
• Device Lot Number: 20641512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown