MAUDE Adverse Event Report: ARTHREX, INC. IBAL TKA,TIB BEARING TRL SZ 8, 12MM; ORTHOPAEDIC TEMPLATE

Model Number	IBAL TKA,TIB BEARING TRL SZ 8, 12MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
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) 2024, it was reported by a sales representative via sems (b)(4) that an ar-623-t812 ibalance tka, tibial bearing trial size 8 was broken during use with no further information provided.There was no effects to the patient reported.This was discovered during a procedure.Additional information was received on 3/29/2024: the impactor was broken when the tibial implant was implanted; the poly trial broke when attempting to trial the sizes.The device broke while being put into the patient, and all fragments were retrieved from the patient.The case was delayed by about a minute when switching to another poly trial size.The case was completed with another trial and finished normally with no adverse effects on the patient.This was discovered during a total knee arthroplasty procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint allegation is confirmed.Based on the image provided from the field, it is evident that the trial has damage around the edges and a piece broken off in the center.Consequently, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to user-applied mechanical forces during insertion.

• Brand Name: IBAL TKA,TIB BEARING TRL SZ 8, 12MM
• 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: 19146753
• Report Number: 1220246-2024-02182
• Device Sequence Number: 7303756
• Product Code: HWT
• UDI-Device Identifier: 00888867215405
• UDI-Public: 00888867215405
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/12/2025

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 8, 12MM
• Device Catalogue Number: AR-623-T812
• Device Lot Number: 132581531
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/17/2025
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown