MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA, FEMORAL IMPACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	IBAL UKA, FEMORAL IMPACTOR
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
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 (b)(6) 2022, it was reported by a sales representative via sems that an ar-611-6 ibal uka, femoral impactor broke during the case on (b)(6) 2022.This was discovered during use with no impact to the patient.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-611-6 batch number 37621833 was received for investigation.Visual inspection identified that the femoral impactor head had broken prior to receipt for investigation.No fragments were returned for analysis.Signs of wore were identified in the shaft of the device.Multiple discoloration spots were observed on the device.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces upon insertion/use.

• Brand Name: IBAL UKA, FEMORAL 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: 15250111
• Report Number: 1220246-2022-05409
• Device Sequence Number: 20430399
• Product Code: LXH
• UDI-Device Identifier: 00888867223875
• UDI-Public: 00888867223875
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 01/06/2023

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: IBAL UKA, FEMORAL IMPACTOR
• Device Catalogue Number: AR-611-6
• Device Lot Number: 37621833
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown