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

Model Number CTX-C001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

It was reported that after a knee arthroscopy, using one (1) novocut suture, the patient experienced pain and swelling in the right knee, and the patient reported feeling a lump inside the right knee.The patient was treated on an additional surgery and is not recovered.

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Manufacturer Narrative

H6, type of investigation was corrected.

Manufacturer Narrative

H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states that the case report forms were reviewed.However, it did not provide any clinical insight into the reported issue of pain, swelling, and feeling a lump in the right knee.Therefore, there were no clinical factors found which would have contributed to the reported event.The patient impact beyond the additional surgery could not be determined.However, it was reported that the patient has not recovered.No further clinical assessment can be rendered at this time.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: NOVOCUT SUTURE MANAGER
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): CETERIX ORTHOPAEDICS, INC; 6500 kaiser dr ste 120; fremont CA 94555
• Manufacturer (Section G): CETERIX ORTHOPAEDICS, INC; 6500 kaiser dr ste 120; fremont CA 94555
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16748741
• MDR Text Key: 313394401
• Report Number: 3009131204-2023-00012
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00853541006129
• UDI-Public: 00853541006129
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2022
• Device Model Number: CTX-C001
• Device Catalogue Number: CTX-C001
• Device Lot Number: M200154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/16/2023
• Supplement Dates Manufacturer Received: 08/14/2023; 08/24/2023
• Supplement Dates FDA Received: 08/18/2023; 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2020
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 93 KG