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

Model Number	CTX-R001
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a knee scope and meniscus repair, the needle of the cartridge got stuck on the novostitch pro repair system and couldn¿t deploy the second time.The procedure was completed with a backup device and no significant delay or further complications reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10.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.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: 10401083
• Report Number: 3009131204-2020-00019
• Device Sequence Number: 2854436
• Product Code: GAT
• UDI-Device Identifier: 00853541006105
• UDI-Public: 00853541006105
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K180531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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: 10/16/2021
• Device Model Number: CTX-R001
• Device Catalogue Number: CTX-R001
• Device Lot Number: M190276
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 08/18/2020
• 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