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

Model Number	IBAL TKA TIB BRNG TRL CR + SZ 6,8MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/13/2023, it was reported by an arthrex employee via sems-06057425 that an ar-603-a608 ibalance tka tib brng trial cr + sz 6,8mm broke when removing the trial from the knee.All fragments were retrieved.The case was completed by opening a new tray.The delay in the case is unknown and no additional anesthesia was administered to the patient.This was discovered during a tka procedure on 10/13/2023, with no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause(s) of the reported failure can be user error using excessive forces.The complaint allegation was confirmed based on the customer attached picture that display the needles bent.

• Brand Name: IBAL TKA TIB BRNG TRL CR + 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: emily shafer ; 8009337001
• MDR Report Key: 18085913
• Report Number: 1220246-2023-08602
• Device Sequence Number: 7692280
• Product Code: HWT
• UDI-Device Identifier: 00888867112773
• UDI-Public: 00888867112773
• 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: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2025

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 BRNG TRL CR + SZ 6,8MM
• Device Catalogue Number: AR-603-A608
• Device Lot Number: 113601712
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown