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

Model Number	IBALANCE TKA, PIN DRIVER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 11/04/2024, it was reported by a sales representative via (b)(4) that an ar-613-91 ibalance tka pin driver had the pin break off inside the pin driver and, therefore, was not able to be utilized during the second half of the procedure.The case continued, and another product from the second instrument set was used.There were no adverse effects on the patient.This was discovered during a procedure, with no reported patient harm.Additional information was received on 11/06/2024: this was discovered during a uni knee arthroplasty procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was noted that the pin hex's edges of ibalance¿ tka, pin driver had damaged.Functional testing was not performed due to the damage to the device.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage.Manufactured date 04/2020.

• Brand Name: IBALANCE TKA, PIN DRIVER
• 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: 20797224
• Report Number: 1220246-2024-08655
• Device Sequence Number: 15142224
• Product Code: LXH
• UDI-Device Identifier: 00888867116900
• UDI-Public: (01)00888867116900(11)200422(10)1392017
• 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): 01/29/2025

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, PIN DRIVER
• Device Catalogue Number: AR-613-91
• Device Lot Number: 1392017
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2020
• 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