MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, OFFSET TOWER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	IBALANCE TKA, OFFSET TOWER
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021 it was reported by a sales representative via email that an ar-613-43 ibalance has a prong that broke apart.This occurred when performing the ligament balancing portion of the tka.The bone quality of the patient was normal.The fragments of the broken device were fully retrieved.Additional information requested.Additional information provided 10/14/2021: a tka was being performed.The device snapped during ligament balancing.No attachment was being used.Case completed using a back up piece.
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.

• Brand Name: IBALANCE TKA, OFFSET TOWER
• Common Device Name: 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: 12737918
• Report Number: 1220246-2021-03868
• Device Sequence Number: 11959133
• Product Code: LXH
• UDI-Device Identifier: 00888867116443
• UDI-Public: 00888867116443
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 11/02/2021

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, OFFSET TOWER
• Device Catalogue Number: AR-613-43
• Device Lot Number: 221343
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 11/02/2021
• Date Device Manufactured: 02/04/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown