BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMB MICRO DRILL

    MDR report key: 2974583 · Received January 17, 2013

    Report

    Report Number
    1811755-2013-90097
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, THE REPORTED EVENT OF THE DEVICE NOT HOLDING A BUR COULD NOT BE CONFIRMED. UPON FOLLOW-UP THE INITIAL REPORTER STATED THAT THE USER FACILITY HAD USED A THIRD PARTY BUR WHICH EXCEEDED THE RECOMMENDED BUR LENGTH FOR THIS DEVICE. THE USE OF THIS THIRD PARTY BUR MAY HAVE CAUSED THE DEVICE NOT BEING ABLE TO RETAIN THE BUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE BUR WAS NOT RETAINED BY THE DRILL AND THE ATTACHMENT AND SPUN ACROSS THE OPERATING ROOM. BACK-UP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE. NO DELAY, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION WERE REPORTED. IT WAS REPORTED THAT NO PARTS OF THE DEVICES ENTERED THE SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27200 REMB MICRO DRILL ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MICRO DRILL MEDIUM STRAIGHT ATTACHMENT| CAT# 100015250, LOT# 11061