MAUDE Adverse Event Report: CETERIX ORTHOPAEDICS NOVOSTITCH DISPOSABLE SUTURE PASSER

Model Number CTX-A001

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

A note of caution is stated in the ifu, "when the lower jaw is advanced do not simultaneously squeeze the orange and black handles unless there is tissue between the lower and upper jaws.This will result in a "dry-fire" that will compromise the needle integrity.If this happens inadvertently, do not use the device clinically." and "bench deployment testing has demonstrated that the device can be reloaded with suture and fully actuated 14 times.Cycling the device in excess of 14 deployments may impact needle integrity and compromise performance." the probable root cause for the needle tip break could be due to cycling the device in excess of 14 deployments, or due to dry-firing the device.(b)(4).

Event Description

During a arthorscopic knee surgery, the needle tip of the device broke off in the patient's knee.The surgeon was able to retrieve the needle tip from the knee during primary procedure.

• Brand Name: NOVOSTITCH DISPOSABLE SUTURE PASSER
• Type of Device: NOVOSTITCH DISPOSABLE SUTURE PASSER
• Manufacturer (Section D): CETERIX ORTHOPAEDICS; 6500 kaiser drive; suite 120; fremont CA 94555
• Manufacturer (Section G): CETERIX ORTHOPAEDICS; 6500 kaiser drive; suite 120; fremont CA 94555
• Manufacturer Contact: divya mavalli ; 6500 kaiser drive; suite 120; fremont, CA 94555 ; 6506145340
• MDR Report Key: 7558936
• MDR Text Key: 109754033
• Report Number: 3009131204-2018-00008
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/24/2019
• Device Model Number: CTX-A001
• Device Lot Number: M170114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 39 YR