MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, NOTCH PREP GUIDE, SIZE 6; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	IBALANCE TKA, NOTCH PREP GUIDE, SIZE 6
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2021
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
It was reported that during a procedure, when the surgeon was using the quick connect to get cage off of femur, the adaptor part broke.All fragments were received and the case was completed by using a new ar-613-106.
Additional Manufacturer Narrative
Complaint confirmed, the dovetail feature is broken.The missing fragment was not returned.The feature could not be measure dude to the damage, however review of the certificate of conformance confirms the material met specifications.Additional damage was observed in the form of abrasion marks on the inner diameter of the device.The cause is undetermined, however likely causes include user-applied mechanical forces.

• Brand Name: IBALANCE TKA, NOTCH PREP GUIDE, SIZE 6
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11991320
• Report Number: 1220246-2021-03280
• Device Sequence Number: 3564729
• Product Code: LXH
• UDI-Device Identifier: 00888867116016
• UDI-Public: 00888867116016
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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, NOTCH PREP GUIDE, SIZE 6
• Device Catalogue Number: AR-613-106
• Device Lot Number: 221326
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 07/12/2021
• Patient Sequence Number: 1