BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QWIX SCREW 5.5MM DIA X 40MM LENGTH STERILE

    MDR report key: 3827639 · Received May 7, 2014

    Report

    Report Number
    9615741-2014-00017
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    October 7, 2011
    Report Date
    April 15, 2014
    Manufacturer
    NEWDEAL SAS
    Product Code
    HWC
    PMA / PMN Number
    K050346
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE FIRST REPORT OF FOUR REPORTS CONCERNING THE SAME PT. THE DEVICE INVOLVED IN THE REPORTED INCIDENT WAS IMPLANTED ON (B)(6)-2011 AND SURGICALLY REMOVED ON (B)(6)-2011. IT WAS REPORTED THE PT (A HEALTHCARE PROFESSIONAL) HAD SURGERY IN HER RIGHT FOOT DUE TO PAIN DUE TO FLAT FEET. A TALONAVICULAR FUSION, FLEXOR TENDON LIGAMENT REPAIR, AND A MEDICAL SLIDE CALCANEAL OSTEOTOMY OF THE RIGHT FOOT WAS PERFORMED ON (B)(6)-2011. AT THE TIME OF SURGERY, THREE QWIX SCREWS WERE IMPLANTED. A K-WIRE WAS USED FOR FIXATION. ON A NON-SPECIFIED DATE AFTER SURGERY THE PT SAID SHE EXPERIENCED PAIN IN HER RIGHT FOOT. ON (B)(6)-2011, THE PT HAD A SURGICAL REMOVAL OF THIS SCREW. IN (B)(6)-2013, PT EXPERIENCED PAIN IN HER FOOT AND A MAGNETIC RESONANCE IMAGING (MRI) WHICH REVEALED A CYST IN THE RIGHT FOOT THAT 'HAD A HOLE IN IT' AND AVASCULAR NECROSIS. PT SAID SHE 'FELT THE K-WIRE THAT WAS USED FOR THE SURGERY AND REMOVED DURING SURGERY CAUSED THE CYST IN HER RIGHT FOOT'. ON (B)(6)-2013 THE PT EXPERIENCED PAIN AND SAID SHE THOUGHT THE CYST 'BROKE' BUT A COMPUTED AXIAL TOMOGRAPHY (CAT) SCAN REVEALED THE CYST WAS PRESENT AND INCREASED IN SIZE. ON (B)(6)-2013 PT HAD SURGERY TO REMOVE THE CYST, BONE GRAFTING WAS DONE USING AUTO-GRAFT BONE FROM HER TIBIA AND A SUBTALAR FUSION WAS PERFORMED. A CAT ON (B)(6)-2014 REVEALED A FRACTURE IN THE RIGHT FOOT. PT REPORTED SHE STILL EXPERIENCES PAIN WHEN WALKING. ON (B)(6)-2014 IN DIRECT CONVERSATION, THE PT SAID HAD AN APPOINTMENT WITH A DIFFERENT SURGEON SCHEDULED FOR (B)(6)-2014. ON (B)(6)-2014, PT SAID SHE PLANNED TO CANCEL THE APPOINTMENT BECAUSE SHE IS LOOKING FOR A JOB. REQUEST WAS MADE BY INTEGRA FOR ADDITIONAL INFO INCLUDING THE OPERATIVE NOTES AND DIAGNOSTIC TESTS THAT WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274881 QWIX SCREW 5.5MM DIA X 40MM LENGTH STERILE NA HWC NEWDEAL SAS ENSK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention