MAUDE Adverse Event Report: CETERIX ORTHOPAEDICS NOVOSTITCH PLUS MENISCAL REPAIR SYSTEM

Model Number	CTX-A002
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During an arthroscopic knee surgery, the upper jaw of the device broke off from the device shaft during use and fell inside the patient's knee.The broken fragment was recovered from the patient's knee during primary procedure.The surgeon opened a new device and successfully completed the procedure with no further issues.The probable root cause for the upper jaw break could be due to surgeon applying excessive torque, or patient factors may have contributed to the break.

• Brand Name: NOVOSTITCH PLUS MENISCAL REPAIR SYSTEM
• Common Device Name: NOVOSTITCH PLUS MENISCAL REPAIR SYSTEM
• Manufacturer (Section D): CETERIX ORTHOPAEDICS; 6500 kaiser drive; suite 120; fremont CA 94555
• MDR Report Key: 8313225
• Report Number: 3009131204-2019-00004
• Device Sequence Number: 2138456
• Product Code: GAT
• UDI-Device Identifier: 00853541006082
• UDI-Public: 00853541006082
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143356
• 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): 02/06/2019

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: 10/18/2019
• Device Model Number: CTX-A002
• Device Lot Number: M170105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 02/06/2019
• 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