BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRE PASS DRILL BIT (1.1MM DIAMETER)

    MDR report key: 1062015 · Received June 12, 2008

    Report

    Report Number
    9616696-2008-00018
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 14, 2008
    Manufacturer
    STRYKER INSTRUMENTS CORK
    Product Code
    HTW
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION. WORK ORDER DOCUMENTATION REVIEWED AND ALL SPECS WERE MET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE IN THE ORBITAL AREA THE WIRE PASS DRILL BROKE. THE SNAPPED TIP WAS RETRIEVED IMMEDIATELY. THERE WAS NO PATIENT INJURY OR INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIRE PASS DRILL BIT (1.1MM DIAMETER) SURGICAL BURS, DRILLS, TAPS, ROUTERS & ACCESSORIES HTW STRYKER INSTRUMENTS CORK 07232017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK