BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD LONG CURVED

    MDR report key: 2082541 · Received April 28, 2011

    Report

    Report Number
    1811755-2011-01476
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL ATTACHMENT WAS RETURNED TO THE MANUFACTURER, AND THE COMPLAINT WAS CONFIRMED. BASED ON THE DEVICE EVAL, A BROKEN BUR WAS FOUND WITHIN THE DRILL ATTACHMENT. THE CAUSE OF THE BUR BREAKAGE IS UNK, HOWEVER, THE INVESTIGATION IS ON-GOING. THE DEVICE COULD NOT BE REPAIRED AND THEREFORE, WAS NOT RETURNED TO THE USER FACILITY. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE INVESTIGATION RESULTS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MIS POSTERIOR FUSION PROCEDURE, THE TIP OF A CUTTING BUR BROKE OFF AND FELL INTO THE SURGICAL SITE. THE DEVICE FRAGMENT WAS LARGE ENOUGH FOR THE SURGEON TO EASILY LOCATE, AND MANUALLY RETRIEVE WITH A MANUAL INSTRUMENT; NO FRAGMENTS REMAIN IN THE PT. BACKUP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE, WITHOUT CAUSING A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED, AS A RESULT OF THIS EVENT. THERE WAS NO PT OR USER INJURY REPORTED, AND NO OTHER ADVERSE CONSEQUENCES ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SD/PD LONG CURVED ERL STRYKER INSTRUMENTS KALAMAZOO 10147

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK