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	Foreign Body In Patient (2687)
Date of Event	10/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the novostich broke while knotting, suture was removed with graspers; the procedure was successfully completed without delay using a back-up device.No other 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, h2, h3, h6: lot number m190284, one spent cartridge, used in treatment, was returned for evaluation.The cartridge was received with disassembled needle assembly.Overall, the cartridge assembly intact with all the components, with no fragments missing.There was no relationship found between the returned cartridge and the reported incident.The suture can break during knotting when suture tensile strength is insufficient to carry applied load.Device designed with suture that conforms to usp 2-0 tensile strength requirements.The instruction for use contains precautions about using of the device under these conditions.Based on the reported issue the probable root cause could be related to surgeon technique issue, though it cannot be confirmed with the information available.Risk management documents were reviewed finding no additional risks that require to be added to the reference document.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.

• 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
• MDR Report Key: 10784668
• Report Number: 3009131204-2020-00035
• Device Sequence Number: 4141676
• Product Code: GAT
• UDI-Device Identifier: 00853541006105
• UDI-Public: 00853541006105
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K063778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2020

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: 10/24/2021
• Device Model Number: CTX-R001
• Device Catalogue Number: CTX-R001
• Device Lot Number: M190284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention