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 Information (3190)
Date of Event	07/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the surgery the novostitch pro needle broke off inside the patient's knee.All the broken pieces were removed from the joint.It is unknown if there was a surgical delay or if there was a back-up device available to complete the procedure.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 not provided batch review was unattainable without a valid lot number provided.The device, used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned for evaluation.Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.It was reported that during the surgery, the needle broke.There were no broken pieces left inside the patient.The likely root cause for the needle tip fracture is when surgeon cycles needle too many times, or advances needle without tissue present between device jaws.The root cause in this case could not be determined because the device was not returned to perform failure analysis.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.Further investigation is not warranted at this time.Should additional information be provided, this complaint will be re-assessed.

• 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: 10440316
• Report Number: 3009131204-2020-00021
• Device Sequence Number: 4093263
• Product Code: GAT
• UDI-Device Identifier: 00853541006105
• UDI-Public: 00853541006105
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/27/2020

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 Model Number: CTX-R001
• Device Catalogue Number: CTX-R001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 08/27/2020
• 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