BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U-SERIES LONG CURVED

    MDR report key: 1873642 · Received September 17, 2010

    Report

    Report Number
    1811755-2010-01191
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DISCARDED THE DRILL ATTACHMENT, SO THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR A QUALITY INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING MINIMALLY INVASIVE SPINE SURGERY, THE BUR BROKE OFF IN THE SHAFT OF THE DRILL ATTACHMENT. THERE WAS NO REPORT OF ANY DEVICE FRAGMENTS FALLING INTO THE SURGICAL SITE. BACKUP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE, CAUSING A 2-5 MINUTE DELAY. THERE WAS NO PATIENT OR USER INJURY REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U-SERIES LONG CURVED DRILLS, BURS, TREPHINES & ACCESSORIES (SIMPLE, POW) HBE STRYKER INSTRUMENTS KALAMAZOO 10123

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK