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

Catalog Number TPS-111-1111

Device Problem Break (1069)

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

Event Date 04/01/2015

Event Type  malfunction  

Event Description

A disposable cutting guide instrument broke following impaction onto the bone during surgery.

Manufacturer Narrative

Review of the device history record indicates that the device was manufactured to specification.

• Brand Name: ITOTAL PS
• Type of Device: TOTAL KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 28 crosby dr; bedford MA 01730
• Manufacturer Contact: karina snow ; 28 crosby dr; bedford, MA 01730 ; 7813459195
• MDR Report Key: 4766041
• MDR Text Key: 21547671
• Report Number: 3004153240-2015-00083
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142404
• 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: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2015
• Device Catalogue Number: TPS-111-1111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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: 51 YR