BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRE PASS DRILL, MEDIUM

    MDR report key: 2822673 · Received November 2, 2012

    Report

    Report Number
    9616696-2012-00283
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 9, 2012
    Manufacturer
    STRYKER IRELAND LTD., INSTRUMENTS DIVISION
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BUR SUBJECT TO THIS INVESTIGATION WAS RETURNED TO THE MFR FOR EVAL, IT WAS VISUALLY CONFIRMED THE HEAD OF THE BUR WAS BROKEN FROM THE SHANK. THE RETURNED BUR WAS MEASURED WHERE POSSIBLE AND ALL CRITICAL SPECIFICATIONS WERE MET. MFG RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE, THE BUR BROKE WHILE CHECKING IT BEFORE USE ON THE PT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT A REPLACEMENT BUR WAS AVAILABLE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIRE PASS DRILL, MEDIUM HBE STRYKER IRELAND LTD., INSTRUMENTS DIVISION 11320017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALTERNATIVE POSSIBLE LOT 12020027| EXPIRATION DATE: 01 JAN 2017