MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL G2; TOTAL KNEE REPLACEMENT SYSTEM

Catalog Number M57250600010

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2015

Event Type  malfunction  

Event Description

The disposable femoral impactor tip ijig broke during use.A small piece broke off the surface but remained attached to the main body of the impactor tip.The surgery was completed successfully.

Manufacturer Narrative

The disposable femoral impactor tip ijig broke during use.A small piece broke off the surface but remained attached to the main body of the impactor tip.The surgery was completed successfully.Review of the device history record indicates that the device was manufactured to specification.

• Brand Name: ITOTAL G2
• Type of Device: TOTAL KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 28 crosby drive; bedford MA 01730
• Manufacturer Contact: karina snow ; 28 crosby drive; bedford, MA 01730 ; 7813459195
• MDR Report Key: 4782191
• MDR Text Key: 5878333
• Report Number: 3004153240-2015-00089
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142161
• 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: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2015
• Device Catalogue Number: M57250600010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR