BEUDAMED
    FDA Adverse Event Injury Summary report: N

    14MM TI CANNULATED FEMORAL NAIL 420MM

    MDR report key: 3052084 · Received April 11, 2013

    Report

    Report Number
    8030965-2013-01571
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 18, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDN
    PMA / PMN Number
    K954856
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. CORRECTED DATA: DEVICE WAS IMPLANTED IN 1998. INITIAL REPORT INCORRECTLY STATED DATE OF IMPLANT AS 1999. CATALOG NUMBER CORRECTED PER LOT NUMBER. INITIAL REPORT INCORRECTLY STATED COMPANY REPRESENTATIVE ALSO. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A FEMORAL NAIL AND INTERLOCK SCREW CONSTRUCT IN 1999 DUE TO A FEMORAL SHAFT FRACTURE WHICH WAS THE RESULT FROM A CAR ACCIDENT IN 1998. IN 2007 IMAGING REVEALED FEMORAL NONUNION. DURING THIS TIME THE PATIENT UTILIZED A CRUTCH AND A CANE ALL THE WHILE EXPERIENCING UNSPECIFIED CONSISTENT PAIN AS WELL AS BACK PAIN. ON (B)(6) 2013, IMAGING REVEALED RIGHT MIDSHAFT FEMORAL FRACTURE NONUNION, IM NAIL, AND 3 BROKEN INTERLOCK SCREWS. ONE SCREW WAS BROKEN PROXIMALLY AND 2 SCREWS WERE BROKEN DISTALLY. AS A RESULT OF THIS THE PATIENT ELECTED TO HAVE THE FEMORAL NAIL CONSTRUCT REMOVED. THE PATIENT RETURNED TO THE OPERATING ROOM AND THE IM NAIL AND THE THREE INTERLOCK SCREW HEADS WERE REMOVED. THE FRAGMENTED PORTION OF ONE SCREW WAS REMOVED AND THE OTHER TWO FRAGMENTED PORTIONS WERE LEFT IN PLACE IN THE PATIENT SINCE IT WAS REPORTEDLY IN SAFE POSITIONS. THIS REPORT IS FOR A 14MM TI CANNULATED FEMORAL NAIL. THIS IS 1 OF 4 PARTS REPORTED FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156932 14MM TI CANNULATED FEMORAL NAIL 420MM JDN SYNTHES GMBH A3IN208

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention