MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL IDENTITY; IMPACTOR HANDLE

Model Number 1080-212

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2023

Event Type  Injury  

Event Description

It was reported that an impactor handle had a broken button mechanism.

Manufacturer Narrative

The device was returned for investigation and it was confirmed the device was broken and the button would not move smoothly.A design change from a multi-component button design to a one-piece button has already been implemented.

• Brand Name: ITOTAL IDENTITY
• Type of Device: IMPACTOR HANDLE
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• Manufacturer (Section G): CONFORMIS, INC.; 600 research dr.; wilmington MA 01887
• Manufacturer Contact: terrance wong ; 600 technology park drive; billerica, MA 01821
• MDR Report Key: 17126908
• MDR Text Key: 317150919
• Report Number: 3004153240-2023-00022
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00810933030582
• UDI-Public: 00810933030582
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1080-212
• Device Lot Number: G190901
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2023
• Initial Date FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization