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

Model Number	1080-212
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an impactor handle had a broken button mechanism.
Additional 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
• Common Device Name: 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
• Report Number: 3004153240-2023-00022
• Device Sequence Number: 17764114
• Product Code: LXH
• UDI-Device Identifier: 00810933030582
• UDI-Public: 00810933030582
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 1080-212
• Device Lot Number: G190901
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown