BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY

    MDR report key: 3941412 · Received July 17, 2014

    Report

    Report Number
    2520274-2014-12641
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    June 20, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT¿S AGE IS APPROXIMATE. DATE OF EVENT: UNKNOWN. THIS REPORT IS FOR AN UNKNOWN HELICAL BLADE/UNKNOWN LOT. IMPLANT DATE: (B)(6) 2014. EXPLANT DATE: UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE HELICAL BLADE WAS INSERTED IN THE NAIL OUT OF THE SLOT MADE FOR THE HELICAL BLADE. THE HELICAL BLADE WAS INSERTED OUT OF THE PROXIMAL LOCKING HOLE. THUS THE NAIL AND HELICAL BLADE WERE LYING SEPARATELY IN THE BONE. MEDICAL/SURGICAL INTERVENTION WAS DONE. ORIGINALLY THE PATIENT HAD AN ACCIDENT AND GOT FRACTURE IN SPINE AND PROXIMAL FEMUR. THE PATIENT WAS OPERATED UPON PROXIMAL FEMUR WITH A LONG PROXIMAL FEMORAL NAIL ANTI-ROTATION NAIL AND HELICAL BLADE (B)(6) 2014 AND AFTER THREE DAYS ALSO HAD PEDICLE SCREWS AND RODS UPON SPINE. DURING A FOLLOW UP VISIT, THE PATIENT COMPLAINT OF PAIN AND NO IMPROVEMENT IN THE FEMUR. A LATERAL X-RAY WAS DONE AND IT WAS FOUND THAT THE HELICAL BLADE WAS OUTSIDE OF THE NAIL. THE PATIENT WAS REVISED AND IMPLANTED WITH LOCAL NINETY-FIVE DEGREE DOUBLE ANGLED BLADE PLATE. THIS REPORT IS FOR AN UNKNOWN HELICAL BLADE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418299 ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention