MAUDE Adverse Event Report: ARTHREX, INC. KEEL PUNCH, SIZE 4-7, IBALANCE TKA; ORTHOPEDIC MANUAL SURG INSTR

Model Number	KEEL PUNCH, SIZE 4-7, IBALANCE TKA
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/19/2021
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 inspection of the returned ar-623-6 identified wear marks to the key seat feature, preventing device to be attached to matting component.The observed condition is normal wear and tear of the device.
Event or Problem Description
It was reported that the attachment site on the ar-623-6 is distorted making it difficult to make a solid connection.This was noticed upon inspection after a tka procedure.

• Brand Name: KEEL PUNCH, SIZE 4-7, IBALANCE TKA
• 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: jared engle ; 8009337001
• MDR Report Key: 19133957
• Report Number: 1220246-2024-02124
• Device Sequence Number: 11942210
• Product Code: LXH
• UDI-Device Identifier: 00888867198371
• UDI-Public: 00888867198371
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/18/2024

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: KEEL PUNCH, SIZE 4-7, IBALANCE TKA
• Device Catalogue Number: AR-623-6
• Device Lot Number: 37621623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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