BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAW BLADE 25MM WIDTH 95MM/1.25MM CUT THICKNESS-STER

    MDR report key: 3727205 · Received April 4, 2014

    Report

    Report Number
    1045834-2014-11680
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 5, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO CONTACT PHONE NUMBER PROVIDED. THE LOT NUMBER OF THE SAW BLADE DEVICE WAS UNKNOWN. THEREFORE, THE DATE OF MANUFACTURING IS UNKNOWN. THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY 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

    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

    THIS IS REPORT 1 OF 2 FOR COM-042627.

    Description of Event or Problem · 1

    REPORT 1 OF 2 FOR THE SAME EVENT: IT WAS REPORTED FROM NETHERLANDS THAT DURING A ¿TKP¿ SURGICAL PROCEDURE OF THE RIGHT KNEE, IT WAS OBSERVED THAT THE BATTERY OSCILLATOR DEVICE AND THE SAW BLADE DEVICE CAME APART. ACCORDING TO THE REPORT, THE SURGEON WAS STANDING ON THE CAUDAL PART OF THE RIGHT KNEE AT APPROXIMATELY THE SAME HEIGHT AS THE LEFT KNEE. WHEN THE SURGEON ATTEMPTED TO ROTATE THE ¿SAW HEAD¿ TO A SUITABLE POSITION, IT WAS OBSERVED THAT THE ¿SAW HEAD¿ WAS IN THE SURGEON¿S RIGHT HAND AND THE ¿HANDPIECE¿ WAS IN THE SURGEON¿S LEFT HAND. IT WAS FURTHER REPORTED THAT THE ¿IRON SPRING¿ OF THE INSIDE OF THE ¿SAW HEAD¿ FELL ON THE TABLE. THE REPORTER STATED THAT THE SURGEON¿S GLOVES WERE DIRTY FROM THE INSIDE OF THE DEVICE AND THE SURGEON WAS ADVISED TO CHANGE GLOVES. THE SURGEON HANDED OVER ¿THE PARTS¿ TO THE STERILE OPERATING ROOM NURSE. AS THE NURSE ¿TRIED TO GET THE SAW BLADE OUT OF THE HEAD, ANOTHER PART (ONE SMALL IRON PART) FELL ON THE STERILE INSTRUMENTS¿. THE NURSE PLACED THE "SAW HEAD¿ IN A BASKET SO IT COULD BE MOVED OUT OF THE STERILE AREA. THE REPORTER INDICATED THAT THE THREE IRON PARTS FROM THE INSIDE WERE LATER FOUND; HOWEVER, IT WAS UNKNOWN WHERE THE PARTS WERE FOUND. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A SPARE DEVICE. THERE WAS PATIENT INVOLVEMENT. THE REPORTER STATED THAT THE PATIENT WAS LAYING ON BACK, WITH RIGHT KNEE IN A FLEXED POSITION, AND LEFT LEG IN AN EXTENDED POSITION ON THE TABLE. THERE WERE NO REPORTS OF INJURIES OR PROLONGED HOSPITALIZATION. 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
    203809 SAW BLADE 25MM WIDTH 95MM/1.25MM CUT THICKNESS-STER BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL HWE DEPUY SYNTHES POWER TOOLS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BATTERY OSCILLATOR DEVICE