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

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2022

Event Type  malfunction  

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 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.

• Brand Name: IBAL TKA TIB BRNG TRL CR + SZ 3,9MM
• Type of Device: 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
• MDR Text Key: 340729336
• Report Number: 1220246-2024-02207
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 00888867112544
• UDI-Public: 00888867112544
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1