BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZNN CMN NAIL 11.5MMX42CM 130 R

    MDR report key: 2925256 · Received January 17, 2013

    Report

    Report Number
    9613350-2013-01267
    Event Type
    Other
    Date Received
    January 17, 2013
    Date of Event
    December 16, 2012
    Report Date
    January 11, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THERE IS NO INDICATION FOR A PRODUCT FAILURE. WITH THE INFORMATION GIVEN SO FAR, NO FURTHER INVESTIGATION IS POSSIBLE. THE ROOT CAUSE FOR THIS EVEN CANNOT BE IDENTIFIED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION ANE AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT RECEIVED A ZNN CMN NAIL 11.5MMX42CM 130 R ON THE RIGHT SIDE ON (B)(6) 2012, THE NAIL BROKE UNDER FULL LOAD AND THE PT UNDERWENT REVISION SURGERY ON (B)(6 )2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26433 ZNN CMN NAIL 11.5MMX42CM 130 R ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDU KWA ZIMMER GMBH 2527867

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R