MAUDE Adverse Event Report: CETERIX ORTHOPAEDICS NOVOCUT; ACCESSORIES, ARTHROSCOPIC

Model Number CTX-C001

Device Problem Failure to Cut (2587)

Patient Problem Insufficient Information (4580)

Event Date 01/19/2023

Event Type  malfunction  

Event Description

Novocut suture manager (knot pusher & suture cutter) would not cut.Opened a new one to continue the procedure.

• Brand Name: NOVOCUT
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): CETERIX ORTHOPAEDICS; 7135 goodlett farms parkway; cordova TN 38016
• MDR Report Key: 16263414
• MDR Text Key: 308360253
• Report Number: 16263414
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/20/2023

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
• Device Operator: Health Professional
• Device Model Number: CTX-C001
• Device Catalogue Number: CTX-C001
• Device Lot Number: M220107
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2023
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 01/30/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1