MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, TIBIAL CUT BLOCK, LEFT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBALANCE TKA, TIBIAL CUT BLOCK, LEFT
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Bone Cement Implantation Syndrome (4583)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the ar-623-94l has a metal burr, near the sawblade slot.
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, the slot was found to be physically damaged.The surfaces have abrasion marks and a large burr was observed on the side of the slot.A likely cause is user-applied mechanical forces.

• Brand Name: IBALANCE TKA, TIBIAL CUT BLOCK, LEFT
• 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: 19181604
• Report Number: 1220246-2024-02387
• Device Sequence Number: 20683586
• Product Code: LXH
• UDI-Device Identifier: 00888867225787
• UDI-Public: 00888867225787
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2024

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, TIBIAL CUT BLOCK, LEFT
• Device Catalogue Number: AR-623-94L
• Device Lot Number: 1001211645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown