MAUDE Adverse Event Report: ARTHREX, INC. IBAL TKA,TIB BEARING TRL SZ 6, 8MM; ORTHOPAEDIC TEMPLATE

Model Number	IBAL TKA,TIB BEARING TRL SZ 6, 8MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 3/4/2024, it was reported by a sales representative via (b)(4) that an ar-623-t608 tibial bearing trial broke.All the fragments were removed from inside the patient.The procedure was continued by using an ar-623-t508 tibial bearing trial before putting in the 6.8mm poly implant.This was discovered during a procedure.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-623-t608 was received for investigation.Functional testing was not able to be performed due to the damage to the device.Upon visual evaluation, the ibalance® tka, tibial bearing trial size 6, was broken.The method used to prepare the bone, as well as the bone quality encountered during the procedure, were not provided.The most likely cause for the reported failure can be attributed to wear and tear.Manufacturing date is 2018.

• Brand Name: IBAL TKA,TIB BEARING TRL SZ 6, 8MM
• Common Device Name: ORTHOPAEDIC TEMPLATE
• 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: jared engle ; 8009337001
• MDR Report Key: 18923962
• Report Number: 1220246-2024-01545
• Device Sequence Number: 7514592
• Product Code: HWT
• UDI-Device Identifier: 00888867215245
• UDI-Public: 00888867215245
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 12/05/2024

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 6, 8MM
• Device Catalogue Number: AR-623-T608
• Device Lot Number: 132581531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown