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); Material Separation (1562)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a meniscal repair surgery, the tip of the cartridge broke off in the knee joint.Although a back-up device was available to complete the procedure, it is unknown if there was a surgery delay.No additional complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10.H3, h6: 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.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 outlines precautionary statements and instructions in regards 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.
Additional Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device tip, attempted correction of a damaged device, or an inadvertent impact 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.
Event or Problem Description
It was reported that during a meniscal repair surgery, the tip of the cartridge broke off in the knee joint.No broken pieces were left in the patient but it is unknown how they were removed.A backup device was available to complete the procedure.No information about surgical delay was provided.No further complications were reported.

• 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: 10744469
• Report Number: 3009131204-2020-00031
• Device Sequence Number: 4086888
• Product Code: GAT
• UDI-Device Identifier: 00853541006105
• UDI-Public: 00853541006105
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K180531
• 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,Followup
• Report Date (Section B): 02/08/2022

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 Expiration Date: 01/02/2022
• Device Model Number: CTX-R001
• Device Catalogue Number: CTX-R001
• Device Lot Number: M190384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 10/29/2020; 02/08/2022
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 10/30/2020; 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2019
• 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: Required Intervention
• Patient Sex: Unknown