BEUDAMED
    FDA Adverse Event Injury Summary report: N

    US NANCY NAIL 450 25/10

    MDR report key: 6604417 · Received June 1, 2017

    Report

    Report Number
    0001825034-2017-03501
    Event Type
    Injury
    Date Received
    June 1, 2017
    Date of Event
    May 2, 2017
    Report Date
    April 30, 2018
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HSB
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE DISTAL NAIL TIP FRACTURED APPROXIMATELY 8MM FROM THE DISTAL END. THE LONGER SECTION¿S DISTAL FRACTURE SURFACE HAS FRACTURE ARTIFACTS THAT SUGGEST A TWO-WAY BENDING FATIGUE FRACTURE. THE SHORTER NAIL SECTION SHOWS NUMEROUS GOUGES, SCRAPES, AND SIGNS OF CONTACT WITH HARD OBJECTS. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET US; HOWEVER, THIS REPORT IS BEING FILED AS ZIMMER BIOMET IN (B)(4), IN MANUFACTURES A SIMILAR DEVICE UNDER 510K NUMBER K993956.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. (B)(4). IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING A TRAUMA FLEXIBLE NAILING PROCEDURE, THE NAIL TIP FRACTURED INTRA-OPERATIVELY. ALL PIECES WERE NOT ABLE TO BE RETRIEVED, AS SOME OF THE NAIL REMAINED STUCK IN THE PATIENT'S BONE. NO FURTHER PATIENT CONSEQUENCES HAVE BEEN REPORTED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING A TRAUMA FLEXIBLE NAILING PROCEDURE, THE NAIL TIP FRACTURED INTRA-OPERATIVELY WHILE REPOSITIONING THE FRACTURE SITE. THE FRACTURED NAIL WAS ABLE TO BE REMOVED WITHOUT ISSUE, AND A NEW NAIL WAS PLACED. NO FURTHER PATIENT CONSEQUENCES HAVE BEEN REPORTED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386845 US NANCY NAIL 450 25/10 ROD, FIXATION HSB BIOMET TRAUMA N/A 5230165

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention| S