BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA

    MDR report key: 3914887 · Received July 4, 2014

    Report

    Report Number
    2520274-2014-12390
    Event Type
    Injury
    Date Received
    July 4, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    PK013527
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE, HRX. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THERE WERE NO MRR¿S, NCR¿S, OR COMPLAINT RELATED ISSUES WITH THIS LOT. A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE RIA SYSTEM IS INTENDED TO CLEAR THE MEDULLARY CANAL OF BONE MARROW AND DEBRIS, SIZE THE MEDULLARY CANAL FOR IMPLANTS OR PROSTHESIS, AND TO HARVEST BONE AND BONE MARROW IN THE TREATMENT OF OSTEOMYELITIS. THE CONDITION OF THE RETURNED DRIVE SHAFT IS CONSISTENT WITH DAMAGE DUE TO WEAR AND FATIGUE. THE DRIVESHAFT HAS A MANUFACTURE DATE OF 5/4/2006. AS THE DRIVE SHAFT IS OVER EIGHT YEARS OLD, IT IS LIKELY THAT THE FAILURE WAS CAUSED BY WEAR OVER TIME. DRAWINGS 314_741 REV. K AND DRAWING 314_741_1_2 REV. B WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN AND APPLICATION. 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.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(4); X-RAYS TAKEN TO ENSURE NO PIECE OF THE INSTRUMENT REMAINED IN THE PATIENT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. LOT NUMBER PROVIDED, 143.82-01, COULD NOT BE VERIFIED; THEREFORE, FURTHER INVESTIGATION CANNOT BE PERFORMED. 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 IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392823 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO SYNTHES MONUMENT 14382-01

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention