BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCAD EXPRESS

    MDR report key: 8018315 · Received October 30, 2018

    Report

    Report Number
    3010673777-2018-00003
    Event Type
    Injury
    Date Received
    October 30, 2018
    Date of Event
    October 4, 2018
    Report Date
    October 29, 2018
    Manufacturer
    NOVASTEP
    Product Code
    JDR
    UDI-DI
    03700879502366
    PMA / PMN Number
    K142111
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT (B)(4) OPENED. WE DON'T HAVE ANY INFORMATION OF THE PATIENT (AGE, SEX, WEIGHT) AND HOW THE EVENT OCCURED (SHOCK OR NOT). BASED ON THE REFERENCE AND LOT NUMBER OF THE BROKEN PART COMMUNICATED BY OUR CUSTOMER, THE DHR CONFIRMS THAT THE PART HAS BEEN MANUFACTURED ACCORDING TO THE SPECIFICATIONS. WITH OUT THE DEFECTIVE PART, WE CAN'T PERFORM DIMENSIONAL ANALYSIS. THE FIRST INVESTIGATION DID NOT PERMIT TO CONCLUDE FOR THIS BREAKAGE. AN UPDATE WILL BE ADDED TO THIS REPORT IN CASE OF WE RETRIEVE MORE INFORMATION. DHR REVIEW (RAW MATERIAL, BLANK PARTS, SEMI-FINISH AND FINISH PRODUCTS): MANUFACTURED ACCORDING TO OUR SPECIFICATIONS; XRAY ANALYSIS: 2 LEGS OF THE STAPLE ARE BROKEN, SUGGESTING THAT A SIGNIFICANT EFFORT ON THE STAPLE HAS BEEN GIVEN; DESCRIPTION OF THE BACH: BATCH NUMBER N°150022; LOT CONSUMPTION: 80 PARTS FULLY SOLD TO OUR CUSTOMER. ANALYSIS OF THE DEFECTIVE PART: NOT RETURNED. DIMENSIONAL ANALYSIS CAN'T BE PERFORM ADDITIONAL TEST (B.17.09.266): 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

    ADVERSE EVENT COMMUNICATED BY OUR CUSTOMER : FIRST COMMUNICATION THE (B)(6) 2018: BREAKAGE OF A STAPLE. NO REFERENCE AND NO LOT NUMBER OF THE IMPLANT. SECOND COMMUNICATION THE (B)(6) 2018: PATIENT HAD INITIAL SURGERY TO CORRECT BUNION DEFORMITY. FEW MONTHS LATER, THE PATIENT HAS EXPERIENCED PAIN. AFTER THE XRAY, SURGEON OBSERVED THAT THE FUSION WAS NOT FULLY DONE. THE SURGEON DECIDED TO PROCEED TO THE EXPLANTATION OF THE STAPLE. REFERENCE OF THE STAPLE: 139-25-2020-S; LOT NUMBER: 150022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860334 ARCAD EXPRESS STAPLE JDR NOVASTEP STAPLE 150022 03700879502366

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention