MAUDE Adverse Event Report: ARTHREX, INC. IBAL TKA TIBIAL BEARNG CR + SZ 9, 8MM; TEMPLATE FOR CLINICAL USE

Model Number	IBAL TKA TIBIAL BEARNG CR + SZ 9, 8MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/27/2022
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-603-a908 tibial bearing broke while attempting to insert the device.While impacting the device cracked cleanly into two pieces.The broken fragment was retrieved from the patient.The bearing was replaced and the case was completed.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-603-a908 was received for investigation.Visual inspection identified breakage to the trial inferior to the ce marking.No fragments were returned for assessment.The probable cause is attributed to damage incurred during the insertion process, as alleged in the event description.

• Brand Name: IBAL TKA TIBIAL BEARNG CR + SZ 9, 8MM
• Common Device Name: TEMPLATE FOR CLINICAL USE
• 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: 13528688
• Report Number: 1220246-2022-04469
• Device Sequence Number: 14605516
• Product Code: HWT
• UDI-Device Identifier: 00888867188129
• UDI-Public: 00888867188129
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/31/2022

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: IBAL TKA TIBIAL BEARNG CR + SZ 9, 8MM
• Device Catalogue Number: AR-603-A908
• Device Lot Number: 113601542
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 03/31/2022
• 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