BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD LONG CURVED

    MDR report key: 3130443 · Received May 24, 2013

    Report

    Report Number
    0001811755-2013-01203
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, THE REPORTED EVENT OF A BUR BREAKING IN THE ATTACHMENT COULD NOT BE CONFIRMED AS NO BROKEN BUR WAS FOUND IN THE ATTACHMENT. THE ATTACHMENT WAS FOUND TO HAVE DAMAGE TO THE NOSE TUBE, WHICH CAN BE CAUSED BY EXCESSIVE FORCE APPLICATION, AND CAN LEAD TO BUR BREAKS DURING USE DUE TO EXCESSIVE SIDE LOADS. THE ATTACHMENT IS NOT A REPAIRABLE DEVICE AND WILL THEREFORE NOT BE RETURNED TO THE USER FACILITY.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LUMBAR FUSION PROCEDURE AT THE USER FACILITY, A BUR BROKE OFF IN THE ATTACHMENT. BACK-UP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE. NO CLINICALLY SIGNIFICANT DELAY, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LUMBAR FUSION PROCEDURE AT THE USER FACILITY, A BUR BROKE OFF IN THE ATTACHMENT. BACK-UP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE. NO CLINICALLY SIGNIFICANT DELAY, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230694 SD/PD LONG CURVED DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO 13093

    Patients

    Seq Age Sex Outcome Treatment
    1 CATALOG 8420107530, BUR, LOT UNKNOWN