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

Model Number	CTX-A004
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	12/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During an arthroscopic knee surgery, one side of the device upper jaw ear and the distal end of the link broke.The break could have resulted from jamming device in and out of the knee or into structures in knee and/or excessively torqueing the device during use.It was reported that a small fragment was removed from the patient's knee during primary procedure.

• Brand Name: NOVOSTITCH PRO MENISCAL REPAIR SYTEM, SIZE 0
• Common Device Name: NOVOSTITCH PRO MENISCAL REPAIR SYTEM, SIZE 0
• Manufacturer (Section D): CETERIX ORTHOPAEDICS; 6500 kaiser drive; suite 120; fremont CA 94555
• MDR Report Key: 8201142
• Report Number: 3009131204-2018-00019
• Device Sequence Number: 1558226
• 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): 12/27/2018

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: 11/15/2020
• Device Model Number: CTX-A004
• Device Lot Number: M180113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR