BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIS PRECISION NEURO, 3.0MM

    MDR report key: 2992553 · Received March 7, 2013

    Report

    Report Number
    0001811755-2013-00460
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEW INFORMATION BECAME AVAILABLE, THE PART NUMBER OF THE BUR WAS IDENTIFIED AS (B)(4).

    Additional Manufacturer Narrative · 1

    THE BUR AND ATTACHMENT SUBJECT TO THIS INVESTIGATION WAS NOT RETURNED FOR EVALUATION. IF THE BUR IS RECEIVED, AN EVALUATION WILL BE PERFORMED AND A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE INSIDE THE ATTACHMENT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THERE WAS A 1 MINUTE DELAY TO THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE INSIDE THE ATTACHMENT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THERE WAS A 1 MINUTE DELAY TO THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98186 MIS PRECISION NEURO, 3.0MM DRILLS, BURRS, TREPHINES & ACCESSORIES HBE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 PART 5100120922, LOT 12072