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

Model Number IBALANCE UKA, TIBIA PEG DRILL

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 06/20/2023

Event Type  malfunction  

Event 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.

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.

• Brand Name: IBALANCE UKA, TIBIA PEG DRILL
• Type of Device: 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
• MDR Text Key: 320048308
• Report Number: 1220246-2023-07336
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867223899
• UDI-Public: 00888867223899
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/29/2023
• Date Device Manufactured: 04/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1