MAUDE Adverse Event Report: ARTHREX, INC. IBAL TKA TIB BRNG TRL CR + SZ 3,9MM; ORTHOPAEDIC TEMPLATE

Model Number	IBAL TKA TIB BRNG TRL CR + SZ 3,9MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed, the device is cracked, and its edges are worn and dented.A likely cause of the damage is user-applied mechanical forces.
Event or Problem Description
On 212022, it was reported by a sales representative via (b)(4) that an ar-603-a309 and trailing inserters were cracked.Surgeon was able to used another set to complete the case without further issues.This was discovered during a tka procedure on (b)(6) 2022.Nothing broke inside the patient.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation confirmed.The device is cracked, and its edges are worn and dented.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive user applied mechanical forces during use.

• Brand Name: IBAL TKA TIB BRNG TRL CR + SZ 3,9MM
• 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: 19154064
• Report Number: 1220246-2024-02207
• Device Sequence Number: 18011793
• Product Code: HWT
• UDI-Device Identifier: 00888867112544
• UDI-Public: 00888867112544
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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 BRNG TRL CR + SZ 3,9MM
• Device Catalogue Number: AR-603-A309
• Device Lot Number: 113601320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2014
• 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