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

Model Number	CTX-R001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during the surgery, both pre-loaded and the first reloading cartridge had no problems placing the suture.The other reloading cartridge was properly inserted and placed in the joint.When actuating the upper jaw with the orange handle, a small metal part came loose.It was not possible to identify if the metal piece was from the instrument or the re-loading cartridge.All the broken pieces were removed from the patient¿s anatomy.No delay or other complications were reported.Smith and nephew back-up device was available to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H6 codes updated.H3, h6: the reported and concomitant devices were received for evaluation.The upper jaw of the delivery device was found to be non-functional but there were no issues with the actuation of the lower jaw of the cartridge.It was determined the device did not contribute to the reported event.The complaint was not confirmed as the failure cannot be attributed to the device reported in this complaint.The failure has been associated with the concomitant device of the novostitch delivery device.A complaint history review concluded this was a repeat issue.A review of risk management files found that the reported failure was documented appropriately.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.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device, used in treatment, was not returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.No containment or corrective actions are recommended at this time.Should additional information be provided, this complaint will be re-assessed.The risk management documentation was reviewed and found to contain this failure mode within the risk file, no updates are required.The instruction for use (ifu) outlines precautionary statements and instructions in regard to the use of the device to avoid damage or non-functionality.A review of the complaint and manufacturing records was performed and there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted 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
• MDR Report Key: 11132615
• Report Number: 3009131204-2021-00002
• Device Sequence Number: 17174991
• Product Code: GAT
• UDI-Device Identifier: 00853541006105
• UDI-Public: 00853541006105
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K063778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2022

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 Model Number: CTX-R001
• Device Catalogue Number: CTX-R001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 02/01/2021; 02/04/2022
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 02/11/2021; 02/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Sex: Male