BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR HANDLE REUSABLE INSTRUMENT

    MDR report key: 19172822 · Received April 24, 2024

    Report

    Report Number
    3004153240-2024-00009
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    March 26, 2024
    Report Date
    April 24, 2024
    Manufacturer
    CONFORMIS
    Product Code
    LXH
    UDI-DI
    00810933030582
    Removal / Correction Number
    RES-91376
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER: D221301 THIS SURGERY WAS WITH DR. (B)(6) AT (B)(6) HOSPITAL. DURING KEEL PREPARATION, IMPACTION CAUSED A SCREW TO FALL OUT OF THE IMPACTOR HANDLE AND INTO THE KNEE. THE SURGEON WAS ABLE TO RETRIEVE THE FALLEN SCREW. THIS INCIDENT DID NOT CAUSE ANY DELAY TO THE SURGERY AND DID NOT HAVE ANY EFFECT ON THE PATIENT. THE HANDLE WAS RETURNED WITH ONE SCREW (SEE IMAGE (B)(4)). IT IS ASSUMED THAT THE SCREW WITHIN THE HANDLE IS NOT THE SAME ONE THAT FELL OUT DURING THE PROCEDURE. FROM THIS OBSERVATION THE FAILURE MODE IS ASSUMED TO BE THAT THE FALLEN SCREW WAS LOOSE. A DESIGN CHANGE THAT CONSTRAINS THE SCREWS WITHIN THE HANDLE HAS BEEN IMPLEMENTED TO PREVENT THIS FAILURE MODE PER (B)(4) (ED-07827 REV AG). NOTE: UPON FURTHER INVESTIGATION, THE HANDLE PROVED TO STILL BE FUNCTIONING AS EXPECTED. ADDITIONALLY, THE BUTTON AND SPRING DID NOT SHOW ANY DAMAGE (SEE IMAGE (B)(4)). ONE THING TO NOTE IS THAT THE SCREW THAT HAD NOT FALLEN OUT OF THE HANDLE WAS EASILY TURNED LOOSE. IT SHOWED LITTLE SIGNS OF LOCTITE, BUT DID HAVE A BIT OF RED DISCOLORATION TOWARDS THE BOTTOM OF THE THREADS, MAKING IT SEEM AS IF THERE WAS SOME LOCTITE LEFT KEEPING IT IN PLACE. THIS LOT WAS PART OF RECALL RC-22-002 (RES# 91376). HOWEVER, WHILE ALL HANDLES WERE ACCOUNTED FOR, NOT ALL THE HANDLES WERE RETURN. DISTRIBUTORS ATTESTED THAT ANY UN-ACCOUNTED FOR HANDLES ASSIGNED TO THEM WERE DESTROYED OR SCRAPPED OR NO LONGER IN THEIR POSSESSION. THE DESIGN FMEA FOR THIS DEVICE, FMEA-02696 REV AJ, WAS REVIEWED. THE REPORTED FAILURE MODE IS CAPTURED BY ROW 264: SCREW FALLS OUT INTO JOINT. A FIELD ACTION HAS BEEN OPENED FROM PREVIOUS REPORTS OF THIS FAILURE MODE. A DESIGN CHANGE HAS ALREADY BEEN IMPLEMENTED TO REDUCE OR ELIMINATE THE OCCURRENCE OF THIS FAILURE MODE. TESTING WAS CONDUCTED TO SUPPORT THIS CHANGE.

    Description of Event or Problem · 0

    THE IMPACTOR HANDLE SCREW CAME OUT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943474 IMPACTOR HANDLE REUSABLE INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH CONFORMIS D221301 00810933030582

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other