BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL IDENTITY IMPACTOR HANDLE

    MDR report key: 16501981 · Received March 8, 2023

    Report

    Report Number
    3004153240-2023-00014
    Event Type
    Injury
    Date Received
    March 8, 2023
    Date of Event
    February 10, 2023
    Report Date
    March 8, 2023
    Manufacturer
    CONFORMIS INC
    Product Code
    LXH
    UDI-DI
    00810933030582
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SCREW CAME LOOSE FROM AN IMPACTOR HANDLE AND WAS ABLE TO BE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1736313 ITOTAL IDENTITY IMPACTOR HANDLE REUSABLE SURGICAL INSTRUMENT LXH CONFORMIS INC 1080-212 E202701 00810933030582

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown Required Intervention