BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCAD EXPRESS

    MDR report key: 7281173 · Received February 19, 2018

    Report

    Report Number
    3010673777-2018-00002
    Event Type
    Injury
    Date Received
    February 19, 2018
    Date of Event
    January 31, 2018
    Report Date
    February 19, 2018
    Manufacturer
    NOVASTEP
    Product Code
    JDR
    PMA / PMN Number
    K142111
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) OPENED. WE HAVE THE DESCRIPTION OF THE PATIENT, AND TREATED INDICATION. BUT WE DON'T HAVE THE REFERENCE OF THE STAPLE, NEITHER THE LOT NUMBER. WE HAVE CONTACTED OUR CUSTOMER TO HAVE MORE INFORMATION AND THE BROKEN PART BUT NOTHING. DESCRIPTION OF THE BREAKAGE: EVEN IF THE SURGEON REPORTED THAT THE STAPLE HAD BROKEN DURING THE EXPLANTATION OF IT, WE CAN NOT CONCLUDE THAT THE EFFORT OR THE METHOD OF EXPLANTATION WAS INAPPROPRIATE. ANALYSIS DID NOT PERMIT TO CONCLUDE FOR THIS BREAKAGE. AN UPDATE WILL BE ADDED TO THIS REPORT IN CASE OF WE RETRIEVE MORE INFORMATION.

    Description of Event or Problem · 1

    ADVERSE EVENT COMMUNICATED BY OUR CUSTOMER: ISSUE: PATIENT HAD INITIAL SURGERY TO CORRECT BUNION DEFORMITY, 2 YEARS AGO. PARTIAL FUSION APPEARED ON BOTH IMAGING AND INTRA-OP DURING REMOVAL, AND PATIENT EXPERIENCED PAIN. THE DOCTOR DECIDED TO REMOVE ANOTHER EXTREMITY MEDICAL (LAG SCREW, X-POST); BUT DURING REMOVAL SURGERY, THE EXPRESS STAPLE BROKE, AND 3/4TH OF THE STAPLE WAS ABLE TO BE REMOVED. THE 1/4TH STILL REMAINS IN PATIENT FOOT. NO GRAFTING OR ADDITIONAL FIXATION WAS NEEDED. STAPLE REFERENCE AND LOT NUMBER NOT COMMUNICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124321 ARCAD EXPRESS STAPLE JDR NOVASTEP NO INFORMATION NO INFORMATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR