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

Model Number	IBALANCE TKA, SMALL IMPACTOR
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
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 04/26/2022, it was reported by a sales representative via sems that qty.2 of an ar-613-98 tka small impactor broke.This was discovered during a tka procedure on (b)(6) 2022.All fragments were retrieved from the patient and the case was completed without further incident.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-613-98 was received for investigation.Visual inspection identified breakage across the c8394-01 notch/bearing impactor, exposing the c8369-01 key seat attachment.Surface damage was also noted across the key seat feature.A probable cause is attributed to user-applied mechanical forces during use.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 14407125
• Report Number: 1220246-2022-04909
• Device Sequence Number: 4909365
• 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): 06/21/2022

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: 113601639
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown