MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, OFFSET TOWER; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	IBALANCE TKA, OFFSET TOWER
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2021, it was reported by a sales representative via sems that an ar-613-43 ibalance tka offset tower was missing a piece from the tip.This was discovered during use in a procedure on 09/15/2021.Additional information 9/22/2021 on (b)(6) 2021, it was reported by a sales representative via sems that an ar-613-43 ibalance tka offset tower was missing a piece from the tip.Per the sales rep, he does not have the piece that was broken off and is not sure when it went missing.They did not notice until after the case on (b)(6) 2021.
Additional Manufacturer Narrative
Complaint confirmed.- visual evaluation revealed that one of the legs of the c8680-01 pin had broken off upon receipt for investigation.No other damaged was observed.The other pin had two legs slightly bend.Measurements were performed on both pins shafts and they were found to met specification.The cause is undetermined; however a most likely cause is the application of prying/leveraging forces to the device during use.

• Brand Name: IBALANCE TKA, OFFSET TOWER
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 12576927
• Report Number: 1220246-2021-03753
• Device Sequence Number: 4522616
• Product Code: LXH
• UDI-Device Identifier: 00888867116443
• UDI-Public: 00888867116443
• 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,Followup
• Report Date (Section B): 11/10/2021

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: 221347
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown