BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 3181399 · Received June 21, 2013

    Report

    Report Number
    0001811755-2013-01448
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 10, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN COMPLETED. (B)(4): INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY FOR VISUAL INSPECTION CORROSION WAS FOUND ON THE DRIVE SHAFT ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORE IMPACTION DRILL HEATED UP DURING A CASE. THERE WAS NO PATIENT OR USER INJURY REPORTED AND NO ADVERSE CONSEQUENCES ALLEGED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORE IMPACTION DRILL HEATED UP DURING A CASE. THERE WAS NO PATIENT OR USER INJURY REPORTED AND NO ADVERSE CONSEQUENCES ALLEGED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283235 CORE IMPACTION DRILL DRIVER, WIRE, AND BONE DRILL, MANUAL DZJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1