MAUDE Adverse Event Report: CETERIX ORTHOPAEDICS NOVOSTITCH PRO MENISCAL REPAIR SYSTEM; NOVOSTITCH PRO MENISCAL REPAIR SYSTEM, SIZE 0

Model Number	CTX-A004, CTX-A003
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were two device handles that had upper jaw break in this clinical case.The device models that were used are ctx-a004 novostitch pro meniscal repair system, size 0 and ctx-a003 novostitch pro meniscal repair system, size 2-0.The lot numbers are m180077 and m180089.For lot number m180077, the date of manufacture is 07/18/2018, use by date is 08/18/2020, and udi number is (b)(4).For lot number m180089, the date of manufacture is 08/09/2018, use by date is 09/09/2020, and udi number is (b)(4).
Event or Problem Description
During an arthroscopic knee procedure, the upper jaw of the device broke in the patient's knee twice.The probable cause for the upper jaw break could be due to poor portal placement, tight knee space, and/or application of excessive torque by the surgeon.

• Brand Name: NOVOSTITCH PRO MENISCAL REPAIR SYSTEM
• Common Device Name: NOVOSTITCH PRO MENISCAL REPAIR SYSTEM, SIZE 0
• Manufacturer (Section D): CETERIX ORTHOPAEDICS; 6500 kaiser drive; suite 120; fremont CA 94555
• MDR Report Key: 8116013
• Report Number: 3009131204-2018-00012
• Device Sequence Number: 11352088
• Product Code: GAT
• UDI-Device Identifier: 00853541006051
• UDI-Public: 00853541006051
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K181772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/18/2020
• Device Model Number: CTX-A004, CTX-A003
• Device Lot Number: M180077, M180089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR