MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL IDENTITY CR; TOTAL KNEE REPLACEMENT SYSTEM

Model Number ED-07827

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that the locking button would not engage the keel punch on the itotal identity impactor handle.The spring inside the impactor handle would not hold onto the keel punch causing it to not function properly.There was no patient impact or major delays in surgery.Inspection of the device did yield a definite cause for the device malfunction.Review of the device history record indicates that the device was manufactured to specification.

Event Description

It was reported that the locking button would not engage the keel punch on the itotal identity impactor handle.The spring inside the impactor handle would not hold onto the keel punch causing it to not function properly.There was no patient impact or major delays in surgery.

• Brand Name: ITOTAL IDENTITY CR
• Type of Device: TOTAL KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• Manufacturer (Section G): CONFORMIS, INC.; 600 research drive; wilmington MA 01887
• Manufacturer Contact: emmanuel nyakako ; 600 technology park drive; billerica, MA 01821 ; 7813459164
• MDR Report Key: 9665396
• MDR Text Key: 181956622
• Report Number: 3004153240-2020-00024
• Device Sequence Number: 1
• Product Code: OOG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ED-07827
• Device Lot Number: G190901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1