MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE UKA, TIBIA PEG DRILL; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBALANCE UKA, TIBIA PEG DRILL
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/21/2023, it was reported by a sales representative via sems that an ar-611-10 tibia peg drill and ar-611-11 femoral peg drill are worn and pieces are starting to shave off.This was discovered during a case and produced debris.
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.
Additional Manufacturer Narrative
Based on the image from the field, it is evident that the distal tip of the ibalance® uka sportsplasty¿, tibial peg drill, is damaged.Therefore, arthrex was able to conclude a most likely cause.The most likely cause of this condition is the excessive force used to pry and/or leverage the device.

• Brand Name: IBALANCE UKA, TIBIA PEG DRILL
• 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: 17413878
• Report Number: 1220246-2023-07336
• Device Sequence Number: 17901907
• Product Code: LXH
• UDI-Device Identifier: 00888867223899
• UDI-Public: 00888867223899
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/26/2025

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 UKA, TIBIA PEG DRILL
• Device Catalogue Number: AR-611-10
• Device Lot Number: 022115
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2021
• 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