MAUDE Adverse Event Report: ARTHREX, INC. IBAL TKA,TIB BEARING TRL SZ 1, 11MM; TEMPLATE FOR CLINICAL USE

Model Number	IBAL TKA,TIB BEARING TRL SZ 1, 11MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/10/2021
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 the ar-623-t112 and ar-623-t111, broke during use.The case was completed without incident by using a new device.
Additional Manufacturer Narrative
Complaint confirmed, evaluation shows the device broke in two.The bridge between the two halves broke off and the fragment was not returned.The inferior side of the device is also dented.A likely cause of the event is user-applied mechanical forces.

• Brand Name: IBAL TKA,TIB BEARING TRL SZ 1, 11MM
• Common Device Name: TEMPLATE FOR CLINICAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12076251
• Report Number: 1220246-2021-03340
• Device Sequence Number: 11688587
• Product Code: HWT
• UDI-Device Identifier: 00888867214972
• UDI-Public: 00888867214972
• 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): 07/07/2021

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: IBAL TKA,TIB BEARING TRL SZ 1, 11MM
• Device Catalogue Number: AR-623-T111
• Device Lot Number: 132581534
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 07/07/2021
• Patient Sequence Number: 1