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

Model Number	IBALANCE TKA, SMALL IMPACTOR
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/22/2021
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 tka procedure, when the surgeon was impacting the trial poly, the tip of the ar 613-98 broke.The case was completed by using another instrument set to get another impactor.
Additional Manufacturer Narrative
Complaint confirmed, the device is broken, and a large piece broke off.The cause is undetermined, however likely causes include user-applied mechanical forces.

• Brand Name: IBALANCE TKA, SMALL IMPACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12091667
• Report Number: 1220246-2021-03347
• Device Sequence Number: 1492648
• Product Code: LXH
• UDI-Device Identifier: 00888867116955
• UDI-Public: 00888867116955
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 07/27/2021

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, SMALL IMPACTOR
• Device Catalogue Number: AR-613-98
• Device Lot Number: 113601336
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 07/27/2021
• Patient Sequence Number: 1