BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNEE NAIL GOLD 10X38 RETRO/TIB

    MDR report key: 6306699 · Received February 7, 2017

    Report

    Report Number
    1020279-2017-00090
    Event Type
    Malfunction
    Date Received
    February 7, 2017
    Date of Event
    January 6, 2017
    Report Date
    July 28, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDS
    PMA / PMN Number
    K981529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED DEVICE HAS BEEN IMPLANTED INTO THE PATIENT DURING A REVISION SURGERY WHICH OCCURED DUE TO BREAKAGE OF A SAME CONFIGURATION DEVICE. THIS REVISION WAS REPORTED UNDER MDR 1020279-2017-00026.

    Description of Event or Problem · 1

    IT WAS REPORTED TO US THAT SHORTLY FOLLOWING THE IMPLANTATION SURGERY THE PATIENT STARTED FEELING PAIN AT THE OPERATIVE SITE. PHYSICIAN TOOK X-RAYS AND THE NAIL WAS FOUND TO BE BROKEN / CRACKED WITHIN THE PATIENT, WITH BREAKAGE / CRACK LOCATED ON THE PROXIMAL DISTAL LOCKING HOLE. EXISTENCE OF REVISION SURGERY OR OTHER MEDICAL INTERVENTION HAVE NOT BEEN COMMUNICATED AND THE IMPLANT REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91858 KNEE NAIL GOLD 10X38 RETRO/TIB NAIL, FIXATION, BONE JDS SMITH & NEPHEW, INC. 13KSM0189

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR