BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMN FEMORAL NAIL, CCD 130, LEFT, 11.5 MM, 30 CM

    MDR report key: 5583849 · Received April 18, 2016

    Report

    Report Number
    0009613350-2016-00572
    Event Type
    Injury
    Date Received
    April 18, 2016
    Date of Event
    March 22, 2016
    Report Date
    March 23, 2016
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED THE DEVICE FOR INVESTIGATION ON (B)(6) 2016. THE INVESTIGATION IS PENDING. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED, THAT THE IMPLANTATION OF A ZNN CMN FEMORAL NAIL, CCD 130, LEFT, 11.5 MM, 30 CM COULD NOT BE COMPLETED ON (B)(6) 2016 DUE TO A WRONG NAIL (ZNN CMN FEMORAL NAIL, CCD 125°, RIGHT, 13 MM, 30 CM) IN THE PACKAGE. ANOTHER NAIL WAS USED TO COMPLETE THE SURGERY. THE SURGERY WAS EXTENDED FOR 80 MINUTES. NO TREND IS IDENTIFIED. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. BOTH NAILS WERE RETURNED FOR INVESTIGATION. AFTER RECEIVING THE NAILS AND PACKAGINGS IT COULD BE CONFIRMED THAT THE 2 LOTS WERE MIXED P. A DOCUMENTS ANALYSIS SHOWED THAT THE 2 AFFECTED LOTS WERE PROCESSED AT THE SAME TIME IN THE WASHING/FINISH AREA (WITH A COUPLE OF INUTE OFFSET), AND THAT THEIR LOT IDENTIFICATION NUMBER ARE VERY SIMILAR. THEREFORE THE ISSUE COULD HAVE ORIGINATED FROM A HANDLING EROR. ZIMMER (B)(4) INITIATED A VOLUNTARY RECALL OF LOT#2840846 AND LOT#2840845. ALL AFFECTED DISTRIBUTORS, HOSPITALS AND SURGEONS HAVE BEN INFORMED ABOUT THE RECALL. THE AFFECTED PRODUCTS WERE RETRIEVED AND DESTROYED ON MAY 23, 2016. ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THAT THE IMPLANTATION OF AN CMN FEMORAL NAIL, CCD 130, LEFT, 11.5 MM, 30 CM COULD NOT BE COMPLETED ON (B)(6) 2016 DUE TO A WRONG NAIL IN THE PACKAGE. ANOTHER NAIL WAS USED TO COMPLETE THE SURGERY. THE SURGERY WAS EXTENDED FOR 80 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238943 CMN FEMORAL NAIL, CCD 130, LEFT, 11.5 MM, 30 CM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS HSB ZIMMER GMBH N/A 2840845

    Patients

    Seq Age Sex Outcome Treatment
    1 Other