BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD LONG CURVED

    MDR report key: 1960070 · Received December 17, 2010

    Report

    Report Number
    1811755-2010-02075
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    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 MFR AND THE COMPLAINT WAS CONFIRMED. BASED ON THE QUALITY INVESTIGATION, 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 WILL NOT BE RETURNED TO THE USER FACILITY. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE INVESTIGATION RESULTS REQUIRE ONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE SPINAL FUSION, A BUR BROKE OFF INSIDE A DRILL ATTACHMENT. A BUR FRAGMENT FELL INTO THE SURGICAL SITE, BUT WAS IMMEDIATELY RETRIEVED BY MANUAL INSTRUMENTATION. NO ADDITIONAL MEDICAL INTERVENTION OR TREATMENT WAS REQUIRED FOR THE PT, DUE TO THIS EVENT. BACKUP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE, CAUSING A 15 MINUTE DELAY. NO PT OR USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SD/PD LONG CURVED DRILLS, BURS, TREPHINES & ACCESSORIES (SIMPLE, POW HBE STRYKER INSTRUMENTS KALAMAZOO 10147

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK