BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5 MM FLUTED BALL.

    MDR report key: 4102533 · Received September 19, 2014

    Report

    Report Number
    1045834-2014-12919
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    PK113476
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO CONTACT PHONE NUMBER PROVIDED. THE LOT NUMBER WAS UNKNOWN. THEREFORE, DEVICE MANUFACTURE DATE IS UNKNOWN. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. 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

    THIS IS REPORT 3 OF 3 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SPINAL SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ATTACHMENT DEVICE HEATED UP. THE REPORTER INDICATED THAT THE ATTACHMENT DEVICE WAS IN USE WITH A DIAMOND BALL CUTTING DEVICE. ACCORDING TO THE REPORT, AFTER 30 SECONDS OF BURRING, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE ¿GOT HOTTER AND HOTTER¿. IT WAS REPORTED THAT THE SURGEON STARTED TO IRRIGATE AND CONTINUED BURRING IN CYCLES OF 10-20 SECONDS, 60-70 ROTATIONS PER MINUTE (RPM) WITH SHORT DOWN TIMES IN ORDER TO SUCTION OFF LIQUIDS IN THE PATIENT. ACCORDING TO THE SURGEON, THE HEAT DEVELOPMENT WAS SLIGHTLY LESS WITH IRRIGATION. THE REPORTER INDICATED THAT THE SURGEON SWITCHED FROM THE DIAMOND BALL TO A FLUTED CUTTER DEVICE TO REDUCE THE HEAT DEVELOPMENT. THE REPORTER STATES THAT THE FLUTED BURR HAD LESS HEAT DURING USE. THE REPORTER STATED THERE WAS NO EXCESSIVE LATERAL FORCE USED DURING THE BURRING. IT WAS CLARIFIED THAT THE MOTOR/ HANDPIECE DEVICE DID NOT HEAT UP. ACCORDING TO THE REPORTER, ¿ROLL-MARKS¿ OF THE BALL BEARING FROM THE ATTACHMENT DEVICE WERE VISIBLE ON BOTH THE DIAMOND BALL AND THE FLUTED CUTTER. HOWEVER, THERE WERE NO ROLL-MARKS VISIBLE ON ANY OF THE CUTTERS USED IN THE OTHER PROCEDURES PERFORMED IN THE HOSPITAL. THE REPORTER STATED THAT DURING THE END OF THE BURRING PROCEDURE, THE SURGEON ACCIDENTALLY PERFORATED THE DURA WITH THE FLUTED CUTTER DEVICE. IT WAS NOT REPORTED WHAT AND/OR IF MEDICAL INTERVENTION WAS PERFORMED AS A RESULT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582801 5 MM FLUTED BALL. DRILLS, BURRS, TREPHINES & ACCESSORIES - ATTACHMENT HBE DEPUY SYNTHES POWER TOOLS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MOTOR DEVICE| DIAMOND BALL CUTTER DEVICE| ATTACHMENT DEVICE