BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCAD EXPRESS

    MDR report key: 8733750 · Received June 26, 2019

    Report

    Report Number
    3010673777-2019-10012
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    April 30, 2019
    Report Date
    June 14, 2019
    Manufacturer
    NOVASTEP
    Product Code
    JDR
    UDI-DI
    03700879502328
    PMA / PMN Number
    K142111
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT (B)(4) OPENED. WE DON'T HAVE ANY INFORMATION ON HOW THE EVENT OCCURED (SHOCK OR NOT). BASED ON THE REFERENCE AND LOT NUMBER OF THE BROKEN PARTS COMMUNICATED BY OUR CUSTOMER, THE DHR CONFIRMS THAT THE PART HAS BEEN MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THESE CONCLUSIONS ARE SUPPORTED BY THE RESULTS OBTAINED FOLLOWING THE INTERNAL CONTROL OF DEFECTIVE PARTS. THE FIRST INVESTIGATION DID NOT PERMIT TO CONCLUDE FOR THIS BREAKAGE. DHR REVIEW (RAW MATERIAL, BLANK PARTS, SEMI-FINISH AND FINISH PRODUCTS) : MANUFACTURED ACCORDING TO OUR SPECIFICATIONS. DESCRIPTION OF THE BATCH : BATCH NUMBER N°170005 ; LOT CONSUMPTION: (B)(4) PARTS FULLY SOLD TO OUR CUSTOMER. ANALYSIS OF DEFECTIVE PARTS : CONFORM TO INTERNAL SPECIFICATION AT LEAST FOR THE WIDTH OF THE DEVICE. OTHER REMARK: ADDITIONAL TEST ((B)(4)) : THE 11TH OF OCTOBER 2017, AN TENSILE STRENGTH TEST HAS BEEN PERFORMED ON THE SMALLEST STAPLE (REF ARCAD 10-09-09) MANUFACTURED BY NOVASTEP. THE PARTS TESTED WERE DELIBERATELY OUT OF SPECIFICATIONS (LEG WIDTH OUT OF SPEC 0.01MM). RESULT : ACCORDING TO THE ASTM 564, 4 STATIC POINTS BENDING TEST WAS CONFORM; 4 DYNAMIC POINTS BENDING TEST WAS CONFORM.

    Description of Event or Problem · 1

    DESCRIPTION: TWO STAPLES (139-15-1414-S, LOT NUMBERS 170005 / 180011 ) WERE IMPLANTED ON (B)(6) 2019 FOR A RADIOLUNATE FUSION. BOTH STAPLES BROKE IN THE PATIENT ON (B)(6) 2019. THE REVISION SURGERY WAS PERFORMED ON THE PATIENT, ON (B)(6) 2019. BOTH BROKEN STAPLES WERE RETURNED TO EXTREMITY MEDICAL FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528966 ARCAD EXPRESS STAPLE JDR NOVASTEP STAPLE 170005 03700879502328

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention