BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD MEDIUM CURVED

    MDR report key: 3092178 · Received May 3, 2013

    Report

    Report Number
    0001811755-2013-01012
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED. FAILURE ANALYSIS IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE REPORTING OF THE EVENT REPORTED ON ASR ID (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, A BUR BROKE OFF IN THE ATTACHMENT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES, OR MEDICAL INTERVENTION WERE REPORTED. IT WAS REPORTED THAT THERE WAS NO INJURY AND NO HARM TO PATIENT OR USER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, A BUR BROKE OFF IN THE ATTACHMENT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES, OR MEDICAL INTERVENTION WERE REPORTED. IT WAS REPORTED THAT THERE WAS NO INJURY AND NO HARM TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194305 SD/PD MEDIUM CURVED DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO 12265

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) MIS PRECISION NEURO, LOT UNKNOWN