BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTUS WRIST 2.5 SYSTEM

    MDR report key: 7925436 · Received October 2, 2018

    Report

    Report Number
    7925436
    Event Type
    Malfunction
    Date Received
    October 2, 2018
    Date of Event
    September 8, 2018
    Report Date
    September 24, 2018
    Manufacturer
    MEDARTIS, INC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HAVING SURGERY ON HER RIGHT WRIST. SURGERY WAS UNDERWAY WHEN THE SURGEON ASKED FOR A FIXATION SCREW. THE SURGICAL TECHNICIAN "PROPER" HANDED THE SURGEON THE APPROPRIATE SIZED SCREW ON THE MEDARTIS SCREWDRIVER. AS THE SCREW WAS BEING PLACED ONTO THE FRACTURE SITE, A PORTION OF THE SCREWDRIVER HAD "BROKE OFF" INTO THE HEAD OF THE SCREW. THE PIECE WAS RETRIEVED (THE PIECE ITSELF NOT BEING IN THE PATIENT), AND RETURNED TO THE BACK TABLE OF THE SURGICAL SET-UP. THE SCRUB TECHNICIAN TOOK THE PIECE AND MATCHED IT TO THE END OF THE SCREWDRIVER, WITH THE SURGEON HAVING BEEN MADE AWARE, AND CONFIDENTLY AFFIRMED THAT NO OTHER PART OF THE SCREWDRIVER WAS MISSING. THIS WAS A NEW SCREWDRIVER, THAT WAS PUT INTO THE MEDARTIS TRAY. THE SAME SURGEON HAD ASKED THAT THE SCREWDRIVER BE REPLACED THE LAST TIME HE USED IT, AND IT HAD. IT WAS THE REPLACEMENT SCREWDRIVER THAT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769863 APTUS WRIST 2.5 SYSTEM SCREW, FIXATION, BONE HWC MEDARTIS, INC A-2710

    Patients

    Seq Age Sex Outcome Treatment
    1 24820 DA