MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL IDENTITY IMPACTOR HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1080-212
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The complaint reports an impactor handle, ed-07827, didn't work during surgery.The surgery was able to be completed successfully with a backup device with a 15 minute delay but no impact was reported to the outcome of the procedure.
Additional Manufacturer Narrative
The complaint reports an impactor handle, ed-07827, didn't work during surgery.The surgery was able to be completed successfully with a backup device with a 15 minute delay but no impact was reported to the outcome of the procedure.The handle was returned for investigation and had a missing screw.The handle was disassembled and the internal mechanism was intact with smooth motion and no jamming.No other damage was detected.The cause of the incident is determined to be the missing screw.This occurrence has been reported with the impactor handle assembly ed-07827 previously and is being monitored.A design change was implemented removing the screws from the device to prevent this failure mode.

• Brand Name: ITOTAL IDENTITY IMPACTOR HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: elizabeth haines ; 600 technology park drive; billerica, MA 01821
• MDR Report Key: 16878658
• Report Number: 3004153240-2023-00017
• Device Sequence Number: 12217999
• 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): 05/02/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1080-212
• Device Catalogue Number: 1080-212
• Device Lot Number: D202201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown