MAUDE Adverse Event Report: CETERIX ORTHOPAEDICS, INC NOVOSTITCH CARTRIDGE 2-0; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	CTX-R001
Medical Device Problem Codes	Break (1069); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample is under evaluation by the manufacturing site.Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a meniscal repair surgery, internal to the patient, the needle of the novostitch did not come out of the lower jaw on deploying the cartridge.The procedure was completed with non-significant delay using a back-up device.No other complications were reported.Preliminary results of investigation had concluded that the tip of the needle was physically broken and would not retract once actuated which makes it a reportable event.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was 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.The patient impact beyond the potential foreign body, possible migration, and local irritation/discomfort cannot be determined.The patient¿s current health status is unknown, and no further clinical medical assessment can be rendered.A visual inspection found suture is not present in the suture pod and debris on the distal tip of the cartridge.A functional evaluation revealed the tip of the needle is broken and would not retract once actuated.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.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.

• Brand Name: NOVOSTITCH CARTRIDGE 2-0
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: 13717572
• Report Number: 3009131204-2022-00005
• Device Sequence Number: 17321123
• Product Code: GAT
• UDI-Device Identifier: 00853541006105
• UDI-Public: 00853541006105
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K063778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/27/2022
• Device Model Number: CTX-R001
• Device Catalogue Number: CTX-R001
• Device Lot Number: M190418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2019
• 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
• Patient Sex: Unknown