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

Model Number	IBALANCE TKA, MODULAR T-HANDLE
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the ar-613-48 is shattered.

• Brand Name: IBALANCE TKA, MODULAR T-HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11655714
• Report Number: 1220246-2021-02897
• Device Sequence Number: 11819891
• Product Code: LXH
• UDI-Device Identifier: 00888867116498
• UDI-Public: 00888867116498
• 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
• Report Date (Section B): 04/13/2021

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, MODULAR T-HANDLE
• Device Catalogue Number: AR-613-48
• Device Lot Number: 67251332
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 04/13/2021
• Patient Sequence Number: 1