BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZNN CMN NAIL 11.5MMX30CM 130 L

    MDR report key: 5570256 · Received April 12, 2016

    Report

    Report Number
    0009613350-2016-00558
    Event Type
    Injury
    Date Received
    April 12, 2016
    Date of Event
    March 11, 2016
    Report Date
    March 14, 2016
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE SURGEON WANTED TO IMPLANT A ZNN CMN NAIL 11.5MMX30CM 130 L. DURING IMPLANTATION IT BECAME OBVIOUS THAT THE NAIL WAS NOT THE ONE INDICATED ON THE LABEL, BUT A ZNN CMN NAIL 13MMX30CM 125 R. AN ALTERNATIVE IMPLANT WAS CHOSEN. 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 UP. A DOCUMENTS ANALYSIS SHOWED THAT THE 2 AFFECTED LOTS WERE PROCESSED AT THE SAME TIME IN THE WASHING/FINISH AREA (WITH A COUPLE OF MINUTE OFFSET), AND THAT THEIR LOT IDENTIFICATION NUMBER ARE VERY SIMILAR. THEREFORE THE ISSUE COULD HAVE ORIGINATED FROM A HANDLING ERROR. ZIMMER (B)(4) INITIATED A VOLUNTARY RECALL OF LOT#2840846 AND LOT#2840845. ALL AFFECTED DISTRIBUTORS, HOSPITALS AND SURGEONS HAVE BEEN INFORMED ABOUT THE RECALL. THE AFFECTED PRODUCTS WERE RETRIEVED AND DESTROYED ON MAY 23, 2016. ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WANTED TO IMPLANT A ZNN CMN NAIL 11.5MMX30CM 130 L. DURING IMPLANTATION IT BECAME OBVIOUS THAT THE NAIL WAS NOT THE ONE INDICATED ON THE LABEL, BUT A ZNN CMN NAIL 13MMX30CM 125 R. AN ALTERNATIVE IMPLANT WAS CHOSEN (ZNN CMN NAIL 11.5MMX30CM 130 L).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224482 ZNN CMN NAIL 11.5MMX30CM 130 L ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS HSB ZIMMER GMBH N/A 2840845

    Patients

    Seq Age Sex Outcome Treatment
    1 Other