BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PERFORATOR DRILL

    MDR report key: 9946748 · Received April 9, 2020

    Report

    Report Number
    1625507-2020-00051
    Event Type
    Injury
    Date Received
    April 9, 2020
    Report Date
    April 9, 2020
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN. NO EVALUATION WAS PERFORMED, AS THE DEVICES WERE NOT RETURNED. IF THE DEVICES ARE RETURNED IN THE FUTURE, PRODUCT ANALYSIS MAY BE PERFORMED. THE DEVICE USER MANUAL WARNINGS SECTION INCLUDES INSTRUCTIONS TO CHECK THE DEVICE FOR DAMAGE BEFORE USE. IF DAMAGE IS FOUND, THE DEVICE SHOULD NOT BE USED. WE WILL CONTINUE TO TRACK AND TREND THIS COMPLAINT TYPE. PMA / 510(K) #: NO INFORMATION AVAILABLE ON DEVICE TO CONFIRM APPLICABLE PMA / 510(K). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERFORATOR BIT PLUNGED WHILE USING AN MR7 DRILL AND A PERFORATOR DRIVER. NO FURTHER INFORMATION REGARDING THE MODEL OR SERIAL NUMBERS OF THE REPORTED DEVICES WERE PROVIDED. ADDITIONAL INFORMATION ABOUT THE EVENT IS BEING FOLLOWED UP FROM THE FACILITY CONTACT PERSON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408652 UNKNOWN PERFORATOR DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MDT POWERED SURGICAL SOLUTIONS UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other