BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1080-646 OFFSET CUP IMPACTOR (BODY) ED-06068 & OFFSET CUP IMPACTOR TRINKET ED-06

    MDR report key: 18282165 · Received December 7, 2023

    Report

    Report Number
    3004153240-2023-00040
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    November 10, 2023
    Report Date
    December 7, 2023
    Manufacturer
    CONFORMIS, INC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BOTH THE STRAIGHT CUP IMPACTOR AND OFFSET CUP IMPACTOR WERE RETURNED FOR ASSESSMENT. THE STRAIGHT CUP IMPACTOR APPEARS TO HAVE BEEN OVERTIGHTENED ONTO THE CUP, RESULTING IN THE INABILITY TO UNTHREAD THE IMPACTOR FROM THE CUP WITH REASONABLE UNASSISTED EFFORT. IN CONVERSATION WITH JAMIE, WHO WAS PRESENT AT THE SURGERY, SHE CONCURRED THAT IT APPEARED THE SCRUB TECH AND SURGEON WERE AGGRESSIVELY TIGHTENING THE CUP IMPACTOR AND OFFERED A WORD OF CAUTION THAT THEY MAY HAVE OVERTIGHTENED IT SO MUCH THAT THEY WOULD NOT BE ABLE TO UNTHREAD IT AFTER CUP IMPACTION. WITH RESPECT TO THE OFFSET CUP IMPACTOR,INVESTIGATORI ASSESSED THE FRICTION OF THE CONNECTION ONCE THE MECHANISM IS ENGAGED AND FOUND IT TO BE CONSISTENT WITH PROPERLY FUNCTIONING OFFSET CUP IMPACTORS. WHILE IT IS POSSIBLE TO OVERPOWER THE FRICTION AND GET THE SCREW HOLES TO SPIN WITH RESPECT TO THE DIRECTION OF THE OFFSET, THE FORCE REQUIRED TO MAKE THE CUP SPIN ON THE END OF THE CUP IMPACTOR WAS AS EXPECTED BY DESIGN AND SIGNIFICANT ENOUGH TO ALLOW FOR PLACEMENT OF THE IMPLANT THROUGH THE INCISION AND INTO THE ACETABULUM. THE CONCLUSION IS THAT BOTH OF THESE INSTRUMENTS ARE FUNCTIONING AS INTENDED AND THAT THE CAUSE OF THIS COMPLAINT IS PRIMARILY RELATED TO THIS BEING THE SURGEONS FIRST TIME USING THIS SYSTEM AND ADJUSTING TO DIFFERENCES BETWEEN OUR INSTRUMENTS AND THOSE THAT HE IS MORE FAMILIAR WITH. I AM CONFIDENT THAT WITH ADDITIONAL EXPOSURE AND USE OF OUR INSTRUMENTS, FAMILIARITY WILL GROW AND HIS OVERALL SURGICAL TIME UTILIZING OUR HIP SYSTEM WILL BE SIMILAR TO WHAT THE SURGEON IS ACCUSTOMED TO WITH OTHER SYSTEMS THAT HE HAS MORE EXPERIENCE WITH. JAMIE HAS FOLLOWED UP WITH THE REP AND SURGEON TO DISCUSS THIS CONCLUSION WITH THEM. DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE FAILURE MODE

    Description of Event or Problem · 0

    ISSUE REPORTED INTRAOPERATIVE INSTRUMENT FAILURE. 1080-646 OFFSET CUP IMPACTOR (BODY) ED-06068

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876577 1080-646 OFFSET CUP IMPACTOR (BODY) ED-06068 & OFFSET CUP IMPACTOR TRINKET ED-06 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH CONFORMIS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown Hospitalization| O