MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, MODULAR T-HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number IBALANCE TKA, MODULAR T-HANDLE

Device Problems Crack (1135); Device Damaged by Another Device (2915)

Patient Problem Insufficient Information (4580)

Event Date 05/20/2021

Event Type  malfunction  

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.

Event Description

It was reported during an tka procedure the ar-613-48, t-handle cracked in half after, the surgeon struck it with a mallet.The hospital discarded the tool.

• Brand Name: IBALANCE TKA, MODULAR T-HANDLE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 11991347
• MDR Text Key: 259471916
• Report Number: 1220246-2021-03282
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867116498
• UDI-Public: 00888867116498
• 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: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IBALANCE TKA, MODULAR T-HANDLE
• Device Catalogue Number: AR-613-48
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2021
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1