BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD MEDIUM CURVED

    MDR report key: 1873458 · Received October 14, 2010

    Report

    Report Number
    1811755-2010-01383
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL ATTACHMENT WAS RETURNED TO THE MANUFACTURER AND THE COMPLAINT WAS CONFIRMED. A VISUAL EXAMINATION OF THE DRILL CONFIRMED THAT A BROKEN BUR SHAFT WAS LODGED IN THE DRILL ATTACHMENT. THE ROOT CAUSE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE INVESTIGATION RESULTS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LUMBAR SPINAL PROCEDURE, A BUR BROKE OFF IN THE DRILL ATTACHMENT. NO DEVICE FRAGMENTS FELL INTO THE SURGICAL SITE. BACKUP EQUIPMENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE, WITHOUT CAUSING A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO PATIENT OR USER INJURY REPORTED, AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SD/PD MEDIUM CURVED DRILLS, BURS, TREPHINES & ACCESSORIES (SIMPLE, POW HBE STRYKER INSTRUMENTS KALAMAZOO 10141

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK