MAUDE Adverse Event Report: ARTHREX, INC. IBAL TKA,TIB BEARING TRL SZ 3, 8MM; ORTHOPAEDIC TEMPLATE

Model Number	IBAL TKA,TIB BEARING TRL SZ 3, 8MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device is not expected to be returned for evaluation.The probable cause of the event could not be determined from the information available and without device evaluation.As no further investigation was able to be performed no change in harm was identified.
Event or Problem Description
It was reported that during a knee procedure, the surgeon was using the hook probe to remove the ar-623-t308, trail and the device broke.All pieces were removed and the case was completed.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-623-t308, batch 132581529 tibial bearing trial was received for investigation.Visual inspection identified breakage along the diameter of the hole at the top of the trial.Approximately 5.81mm of the material remained bent at the breakage site.The observed condition is most likely due to user applied mechanical forces during use, such as through prying/leveraging the trial during the removal process using the hook probe detailed in the event description.The fragment generated during the event was not returned for analysis.

• Brand Name: IBAL TKA,TIB BEARING TRL SZ 3, 8MM
• Common Device Name: ORTHOPAEDIC TEMPLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11842692
• Report Number: 1220246-2021-03119
• Device Sequence Number: 3831163
• Product Code: HWT
• UDI-Device Identifier: 00888867215061
• UDI-Public: 00888867215061
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 06/14/2021

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 3, 8MM
• Device Catalogue Number: AR-623-T308
• Device Lot Number: 132581529
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/14/2021
• Patient Sequence Number: 1