MAUDE Adverse Event Report: CONFORMIS INC 1080-212 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	09/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the set screw dislodged from locking mechanism on the universal impactor handle during tibial component implantation and fell in to the joint.The small screw was located and removed before closure.There was a brief delay and no injury or harm.1080-212 itotal identity impactor handle.
Additional Manufacturer Narrative
Initial complaint was issued sept 13, 2022 a impactor handle, ed-07827.The serial was 0511662.This is a black rubberized model of handle.The complaint reports an impactor handle, ed-07827, which had a shoulder screws that dislodged during tibial impaction.The screw fell into a joint but was removed before closure.There was brief delay in surgery, but no reported harm or injury.

• Brand Name: 1080-212 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 drive; wilmington MA 01887
• Manufacturer Contact: elizabeth haines ; 600 technology park drive; billerica, MA 01821
• MDR Report Key: 16258855
• Report Number: 3004153240-2023-00003
• Device Sequence Number: 5019883
• Product Code: LXH
• UDI-Device Identifier: 00810933030582
• UDI-Public: 00810933030582
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1080-212
• Device Catalogue Number: 1080-212
• Device Lot Number: 0511662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Unknown