BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 3914888 · Received July 4, 2014

    Report

    Report Number
    2520274-2014-12391
    Event Type
    Injury
    Date Received
    July 4, 2014
    Report Date
    June 9, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THIS REPORT IS FOR ONE UNKNOWN TUBULAR PLATE/UNKNOWN LOT. APPROXIMATELY EIGHTEEN MONTHS PRIOR TO JUNE 9, 2014 (B)(4); X-RAYS TAKEN TO ENSURE NO PIECE REMAINED IN THE PATIENT. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TIBIAL REVISION PROCEDURE FOR NON-UNION OF THE DISTAL TIBIA AND FIBULA THAT WAS IMPLANTED APPROXIMATELY EIGHTEEN MONTHS AGO. THE PROCEDURE INCLUDED THE FAILURE OF A 1/3 TUBULAR PLATE DISTAL FIBULA PLATE THAT BROKE. THE HARDWARE WAS COMPLETELY REMOVED. THE PLATE WAS BROKEN BUT THE SEVEN SCREWS WERE FULLY INTACT. THE FIBULA HEALED AND THE TIBIA DID NOT HEAL. THE SURGEON WANTED TO HARVEST BONE GRAFT BY REAMING IRRIGATION ASPIRATOR (RIA) OF THE LATERAL FEMUR. AFTER THE SURGEON CHUCKED UP THE DRIVE SHAFT (PART NUMBER 314.743) TO CONNECT TO THE DRILL AND THE SURGEON WAS TWO THIRDS OF THE WAY THROUGH THE FEMUR AND THE DRIVE SHAFT BROKE IN TWO WHERE THE CHUCK AND RIA MEET. THE SURGEON HARVESTED A SUFFICIENT AMOUNT OF BONE GRAFT SO THIS DID NOT CAUSE DELAY OR AFFECT THE PROCEDURE OUTCOME. AN X-RAY WAS TAKEN TO CONFIRM NOTHING WAS LEFT IN THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED. THIS REPORT IS FOR ONE UNKNOWN TUBULAR PLATE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392805 PLATE,FIXATION,BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention