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

Model Number	CTX-C001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Additional Manufacturer Narrative
H6, type of investigation was corrected.
Additional 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
• Common Device Name: 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
• Report Number: 3009131204-2023-00012
• Device Sequence Number: 12893806
• Product Code: NBH
• UDI-Device Identifier: 00853541006129
• UDI-Public: 00853541006129
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 08/14/2023; 08/24/2023
• Initial Report FDA Received Date: 04/16/2023
• Supplement Report FDA Received Date: 08/18/2023; 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 93 KG