BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT CONTAINING CC1 P1 AND THE IP INTRODUCER

    MDR report key: 4788674 · Received May 19, 2015

    Report

    Report Number
    9617494-2015-00003
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 14, 2015
    Report Date
    April 23, 2015
    Manufacturer
    GMS - GESELLSCHRAFT FUR MEDIZINISCHE SODENTECHNIK - N
    Product Code
    GWM
    PMA / PMN Number
    K040235
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Additional Manufacturer Narrative · 1

    THE REASON FOR THE USE OF THIS UNIT IP1 P WAS BECAUSE THE PT HAS A SERIOUS SUBARACHNOID HEMORRHAGE.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION 07/13/2015. EVAL RESULTS: ONE P1 SET WITH BROKEN DRILL STOP AND A SINGLE DRILL STOP WERE RETURNED. THE OPTICAL INSPECTION SHOWED THAT THE IP1 WAS NOT IN USE JUST THE DRILL STOPS WERE USED AND DAMAGED WHILE ADJUSTING. THE DRILL STOPS BROKE AT THE AREA WHERE THE SET SCREW IS SITUATED. TWO POSSIBLE LOTS OF IP1 INTRODUCER (INCLUDING THE DRILL STOP) HAD TO BE ANALYZED. IP1 LOT 200115 & LOT 050315, NO ABNORMALITIES COULD BE DETERMINED. NO TREND COULD BE DETERMINED AFTER CHECKING THE TRACKWISE DATABASE. CONCLUSION: THE ONLY DIFFERENCE BETWEEN BOTH TESTS WAS THE GAMMA RADIATION DOSE WHICH CAN BE SEEN AS THE REASON OF BROKEN DRILL STOPS. THE MALFUNCTION DESCRIBED IN THE COMPLAINT DESCRIPTION COULD BE REPRODUCED AT (TOO) HIGH SCREWING FORCES.

    Description of Event or Problem · 1

    THE FIRST REPORT OF TWO INVOLVING AN 1P1 P. THE EVENT WAS INITIALLY DESCRIBED AS FOLLOWS, BREAKAGE OF THE "STOP NUT" IN WHITE PLASTIC (PLACED ON THE ROD) OF PTIO2 PROBE DURING ATTEMPT TO CLAMP. THE EVENT WAS FURTHER EXPLAINED AS: "THE PART BROKEN IS THE ADJUSTABLE DRILL STOP WITH SET SCREW OF THE INTRODUCER". THE PROBE IS OK. THE KIT IS IN TWO PARTS THE INTRODUCER AND THE PROBE. AS THERE WAS NO ISSUE WITH THE INTRODUCER THEY DID NOT USE THE PROBE. THE INTRODUCER WAS IN CONTACT WITH PT. NO CONSEQUENCES FOR THE PT. THERE WAS A DELAY WHICH WAS THE TIME NEEDED TO OPEN ANOTHER KIT. THERE WERE TWO UNITS USED ON THE SAME PT WITH THE SAME INCIDENT, AND SAME PRODUCT ID BUT 2 DIFFERENT LOT. THE PART BROKEN IS THE ADJUSTABLE DRILL STOP WITH SET SCREW OF THE INTRODUCER. THE PROBE ARE OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324193 KIT CONTAINING CC1 P1 AND THE IP INTRODUCER LICOX BOLTS CATHETERS & KITS GWM GMS - GESELLSCHRAFT FUR MEDIZINISCHE SODENTECHNIK - N 060215

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR