MAUDE Adverse Event Report: CONFORMIS INC ITOTAL IDENTITY IMPACTOR HANDLE; REUSABLE SURGICAL INSTRUMENT

Model Number	1080-212
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Misassembly by Users (3133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a screw came loose from an impactor handle and was able to be recovered.
Additional Manufacturer Narrative
Email complaint was issued feb, 10th, 2023 for the impactor handle ed-07827.The lot number on the device is e202701.This indicates a manufacture date of may 27th, 2020 per wi-0501-13 rev ab, production identifier method for direct part marking.One of the 2 set screws fell loose during tibial preparation/keel punch.The screw did fall into the incision, but was recovered with a pair of forceps.It did not prolong the surgery more than 15 minutes, the screw and impactor handle were removed and set aside, and new tray was opened to finish the case.No injury has been reported.There is no any impact to surgery.Handle was returned for evaluation.There was no noted loctite on a screw, which is the likely reason why the screw fall out of a handle 3/2/2023 after reviewing the investigation, the reportable status was updated to be reportable.The screw did fall into the incision, although the screw was seen and removed with no other patient impact.

• Brand Name: ITOTAL IDENTITY IMPACTOR HANDLE
• Common Device Name: REUSABLE SURGICAL INSTRUMENT
• Manufacturer (Section D): CONFORMIS INC; 600 technology park drive; fourth floor; 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: 16501981
• Report Number: 3004153240-2023-00014
• Device Sequence Number: 3302241
• Product Code: LXH
• UDI-Device Identifier: 00810933030582
• UDI-Public: 00810933030582
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2023

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: E202701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Unknown