BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNANAIL 10 X 300MM TTC FUSION NAIL

    MDR report key: 15126693 · Received July 28, 2022

    Report

    Report Number
    3007593722-2022-00003
    Event Type
    Injury
    Date Received
    July 28, 2022
    Date of Event
    May 23, 2022
    Report Date
    July 23, 2022
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    JDS
    PMA / PMN Number
    K113828
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022, (B)(4), DJO F&A SR. RAC, WAS SPEAKING TO (B)(4), DJO F&A SR. SALES TERRITORY MANAGER, WHEN HE STATED NEEDED TO REPORT OF A DYNANAIL REMOVAL CASE THAT TOOK PLACE ON (B)(6) 2022 WITH DR. (B)(6) AT (B)(6) HOSPITAL. THE REMOVAL WAS FOR DYNANAIL 10 X 300 MM LOT D0033 (PART NUMBER 1200-01-1030). (B)(4) STATED THAT HE DID NOT HAVE THE PATIENT DETAILS AS HE WAS NOT PRESENT AT THE CASE BUT WAS SENT THE BELOW PRE-OPERATIVE X-RAYS BEFORE THE DYNANAIL REMOVAL CASE OCCURRED. AT THE TIME OF THE REPORTED COMPLAINT, IT WAS UNKNOWN WHY THE DYNANAIL WAS REMOVED. ON 01JUN2022 COMPLAINT INVESTIGATION (B)(4) WAS INITIATED, THE PART WAS RETURNED AND AN MDR ASSESSMENT WAS COMPLETED AND AS SALES REPRESENTATIVE MIKE EPSTEIN CONFIRMED THAT THERE WAS NO PATIENT PAIN OR HARM PRIOR TO THE REMOVAL CASE, IT WAS DETERMINED THAT AN MDR REPORT WAS NOT NECESSARY. FURTHER INFORMATION WAS PROVIDED BY (B)(6) HOSPITAL FELLOW AMAR REGULATION 07JUL2022 AND CONFIRMED THAT THE BROKEN NAIL AND NON-UNION OF BONE WAS OBSERVED DURING THE 1 YEAR FOLLOW UP APPOINTMENT. THE PATIENT WAS A 77 YEAR OLD FEMALE CONFIRMED TO HAVE CHRONIC DROP FOOT SYNDROME IN THE LEFT LEG, THUS NECESSITATING THE IMPLANTATION OF THE DYNANAIL IN THE LEFT LEG. NO HARDWARE BREAKAGE OR PAIN WAS REPORTED BY THE PATIENT UP TO 2 WEEKS PRIOR TO THE 1 YEAR APPOINTMENT. FROM THE TIME OF THE ORIGINAL IMPLANT THE PATIENT WOULD WALK WITH THE RIGHT LEG FIRST FOLLOWED BY THE LEFT LEG, HOWEVER AT A POINT 2 WEEKS PRIOR TO THE 1 YEAR APPOINTMENT, THE PATIENT REPORTED AN INCIDENT OF STEPPING FIRST WITH THE LEFT LEG AND MINOR PAIN IN THE LEFT ANKLE IMMEDIATELY AFTER THE INCIDENT. THE PATIENT REPORTED USING A CANE FOR THE REMAINING 2 WEEKS PRIOR TO THE APPOINTMENT TO MITIGATE THE PAIN AND DURING THE APPOINTMENT THE X RAYS CONFIRMED THE NAIL BREAKAGE. WHILE AN MDR WAS INITIALLY NOT DEEMED AS NECESSARY, THE POST-OPERATIVE PATIENT NOTES REPORTING PATIENT PAIN THAT POTENTIALLY CORRESPONDED TO THE NAIL BREAKAGE WARRANTED AN MDR REPORT TO THE FDA PER QSF-8.2.1.7. THIS MDR HAS BEEN FILED WITHIN THE 30 DAY REQUIREMENT, AS NOT ALL NECESSARY INFORMATION FOR THE COMPLAINT WAS PROVIDED UNTIL 07JUL2022.

    Description of Event or Problem · 0

    MEDSHAPE WAS NOTIFIED OF A DYNANAIL REMOVAL CASE THAT TOOK PLACE DUE TO OBSERVED BONE NON-UNION, NAIL BREAKAGE AND PATIENT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484072 DYNANAIL 10 X 300MM TTC FUSION NAIL NAIL, FIXATION, BONE JDS MEDSHAPE, INC. 1200-01-1030 D0033

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Other