MAUDE Adverse Event Report: ARTHREX, INC. IBAL TKA,TIB BEARING TRL SZ 4, 8MM; TEMPLATE FOR CLINICAL USE

Model Number	IBAL TKA,TIB BEARING TRL SZ 4, 8MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
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
On (b)(6) 2021 it was reported by a sales representative via sems that an ar-623-t408 tibial bearing was trialing for the poly thickness when the poly broke.This occurred during a procedure, the surgeon completed the case by opening a new tray and another trial poly was used.There was no patient effect reported.

• Brand Name: IBAL TKA,TIB BEARING TRL SZ 4, 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: 13967621
• Report Number: 1220246-2022-04679
• Device Sequence Number: 12051684
• Product Code: HWT
• UDI-Device Identifier: 00888867215122
• UDI-Public: 00888867215122
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• 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,TIB BEARING TRL SZ 4, 8MM
• Device Catalogue Number: AR-623-T408
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 03/31/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown