BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIKDRIVE BATTERY POWERED SCREWDRIVER MINI

    MDR report key: 3962788 · Received July 29, 2014

    Report

    Report Number
    0008010177-2014-00192
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT THE DEVICE RAN CONTINUOUSLY COULD NOT BE CONFIRMED. THE RETURNED DEVICE WAS FORWARDED TO THE SUPPLIER. THE RESULT OF THE INVESTIGATION OF OUR SUPPLIER INDICATED THAT THE QDM, CATALOG # 62-50101, SN # (B)(4) DID WORK AS SPECIFIED. IT WAS STATED THAT THE HOUSING SHOW MARKS OF HARD IMPACTS. BASED ON PREVIOUS PERFORMED INVESTIGATIONS AND THE TROUBLESHOOTING GUIDELINES THE MOST LIKELY ROOT CAUSE COULD HAVE BEEN THAT THE DEVICE WAS USED UNDER TOO HOT CONDITIONS, EXPOSED TO HARD IMPACTS CAUSING A TEMPORARILY SENSOR FAILURE OR AN INSUFFICIENT CLEANING / MAINTENANCE PROCEDURE LEADING TO THE REPORTED RUN ON SITUATION. THEREFORE THIS EVENT COULD BE ATTRIBUTED TO A USER RELATED ISSUE. NO INDICATION WAS FOUND THAT THE DETERMINED OBSERVATION WAS A DESIGN, MATERIAL OR MANUFACTURING PROCESS RELATED ISSUE.

    Description of Event or Problem · 1

    PER THE SALES REPRESENTATIVE, THERE ARE MULTIPLE QUIKDRIVES THAT WILL NOT OPERATE. FOUR OF THEM WILL NOT OPERATE AFTER A BATTERY IS ATTACHED AND ONE CONTINUOUSLY RUNS. THERE WAS A FIFTH ONE THAT IS WORKING AND WAS ABLE TO BE USED IN SURGERY.

    Description of Event or Problem · 1

    PER THE SALES REPRESENTATIVE, THERE ARE MULTIPLE QUIKDRIVES THAT WILL NOT OPERATE. FOUR OF THEM WILL NOT OPERATE AFTER A BATTERY IS ATTACHED AND ONE CONTINUOUSLY RUNS. THERE WAS A FIFTH ONE THAT IS WORKING AND WAS ABLE TO BE USED IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441842 QUIKDRIVE BATTERY POWERED SCREWDRIVER MINI INSTRUMENT GEY STRYKER LEIBINGER FREIBURG 4736

    Patients

    Seq Age Sex Outcome Treatment
    1