BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILOT DRILL

    MDR report key: 1222510 · Received November 5, 2008

    Report

    Report Number
    9616696-2008-00073
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    September 26, 2008
    Report Date
    October 17, 2008
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HTW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION. IT WAS REPORTED THAT THE CUSTOMER RE-USED THE DEVICE AND ADMITTED THAT THE CAUSE OF THE FAILURE MAY HAVE BEEN DUE TO THE DEVICE BEING RE-USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DRILLING OF A BONE IN THE MOUTH THAT THE DRILL BROKE. IT WAS FURTHER REPORTED THAT THE DRILL WAS LEFT IN THE PATIENT'S BONE AND THAT IT WAS EMBEDDED COMPLETELY. IT WAS REPORTED THAT THE DRILL WAS USED PREVIOUSLY, RESTERILIZED AND IT WAS BEING REUSED AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILOT DRILL DEVICE DRILLS, BURS TREPHINES & ACCESSORIES HTW STRYKER IRELAND LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other