BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCAD

    MDR report key: 6053978 · Received October 25, 2016

    Report

    Report Number
    3010673777-2016-00004
    Event Type
    Injury
    Date Received
    October 25, 2016
    Report Date
    October 25, 2016
    Manufacturer
    NOVASTEP
    Product Code
    JDR
    UDI-DI
    03700879501291
    PMA / PMN Number
    K142111
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) OPENED : ALL INVESTIGATIONS DONE AT THIS TIME CONFIRMED THESE BATCHES OF ARCAD WERE PRODUCED AND CONTROLLED CONFORM TO NOVASTEP SPECIFICATIONS. COMMENT : 2 STAPLES HAVE BEEN USED FOR THIS MTP ARTHRODESIS, WE DON'T KNOW WHICH STAPLE LOT NUMBER HAS BROKEN IN THIS CASE. FOR INFORMATION, WE ADD IN THIS MDR ALL INFORMATION RELATED TO THE 2ND STAPLE. MODEL # CATALOG # : ARCAD CS041818, LOT # : C00554, EXPIRY DATE : 09/01/2020, (B)(4), MANUFACTURING DATE : 11/17/2015. DEVICE EXPLANTED BY MANUFACTURER: NOT EXPLANTED.

    Description of Event or Problem · 1

    HOSPITAL CALLED NOVASTEP SALES REP ON 29TH SEPTEMBER 2016 AND REPORTED ARCAD 18 COMPRESSIVE STAPLE BREAKAGE. ARCAD 18-16-18 COMPRESSIVE STAPLE WAS DETECTED AS BROKEN BY THE SURGEON DURING THE ANALYSIS OF XRAY PERFORMED DURING A PATIENT FOLLOW UP VISIT. WEIGHT OF THE PATIENT ASSOCIATED TO THE USE OF ONLY TWO ARCAD 18 STAPLES TO PROCEED MTP ARTHRODESIS (TOO WEAK) IS EXPECTED TO BE THE ROOT CAUSE OF THIS BREAKAGE. ASSEMBLY SHOULD HAVE BEEN DONE USING BIGGER STAPLES OR ADDITIONAL DEVICES ASSOCIATED WITH TWO ARCAD 18 COMPRESSIVE STAPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704533 ARCAD STAPLE JDR NOVASTEP ARCAD C00684 03700879501291

    Patients

    Seq Age Sex Outcome Treatment
    1 Other